The GxP Recruitment Company Limited

The GxP Recruitment Company Limited which are governed by GxP guidelines.

An independent scientific recruitment company that specialises in the sourcing of biopharmaceutical and research professionals for companies throughout the U.K. Recruitment Specialists to industries governed by GxP guidelines and for professionals with experience in those industries; including, but not limited to, Pharmaceuticals, Biologics, Medical Devices, R&D across all business units at all levels.

We have a brand new role for an experienced QC Stability Analyst for a 1 year contract based in Grangemouth, Scotland. I...
07/05/2024

We have a brand new role for an experienced QC Stability Analyst for a 1 year contract based in Grangemouth, Scotland. Ideally the post holder will have previous stability studies experience combined with an analytical chemistry background, and have worked previously to GMP.
Please email us at [email protected] to register interest.

07/05/2024

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29/08/2020

GxP Recruitment invites applications on behalf of our biopharmaceutical client based in Grangemouth, Scotland where an excellent opportunity now exists for a QC Lab Assistant to join their team on a 12 month contract.
Key duties include:
• Support laboratory personnel in Quality Control department to ensure all PPE, consumables and materials are available for testing.
• Ensuring all laboratory areas and QC facilities are cleaned and maintained in accordance with housekeeping procedures and processes and remain in an inspection ready state.
• Arrange subcontract of QC testing and dispatch to approved suppliers as appropriate.
• Assist in ensuring adequate stocks of material and equipment for effective operation of laboratories
• Carry out general maintenance and housekeeping of equipment and laboratories
• Assist in co-ordination of incoming deliveries and dispatches
• Ensuring all storage units, fridges, freezers, incubators are defrosted and cleaned as defined by housekeeping and cleaning strategy.
• Maintain Quality Control information systems as applicable.
• Assist in investigation of quality incidents and other departmental incidents.
• Complete GMP documentation in a compliant manner and complete any assigned QMS documentation in a timely manner.
The ideal candidate:
• Some previous experience in a laboratory/GMP environment
• Ability to organise own work within a busy lab
• Experience following SOPs and record keeping

29/08/2020

GxP Recruitment invites applications on behalf of our biopharmaceutical client in Central Scotland where an excellent opportunity exists for a Protein Scientist to join their team, initially on a 1 year contract which is likely to become permanent thereafter.
Job Purpose:
To carry out laboratory experimentation to support the Technology Transfer, Development and Siting of new processes for GMP, and to assist in manufacture.
Key duties include:
 Plan and carry out experiments and analysis, as outlined by the project lead, to ensure effective technology transfer and development of fit for purpose processes in line with customer requirements.
 Record all laboratory work in standard official notebooks and compile results and observations
 Client communication (as required) in a professional manner.
 Follow protocols and procedures
 Carry out manufacturing support for first time manufacturing operations, troubleshoot scaled-up processes and providing first-line technical support.
 Ensure the development laboratory and other associated areas are kept in control and in a compliant manner.
 Provide on the job training to new or inexperienced personnel in both laboratory procedures and equipment use

The ideal candidate:
• Working knowledge of process development and Protein Chemistry and analysis
• Ideally Master’s degree educated in a Chemistry discipline with min. 1 year experience in industry OR BSc. plus 2 years experience min.
• Excellent communication skills

25/08/2020

GxP Recruitment invites applications on behalf of our biotechnology client based near Glasgow where an excellent opportunity has arisen for a QA Specialist with focus on Supplier Assurance.

The position will have responsibility for ensuring Quality Assurance activities relating to product support for the manufacture, packaging, testing, storage and distribution of manufactured drug products are compliant with current GMP and company expectations.
Key duties include:
• Managing vendor approval system (initial and review).
• Maintaining vendor files electronically and physically.
• Managing supplier performance and liaising with suppliers to complete investigations (vendor complaints) into supplier material defects.
• Progress and manage vendor change notifications ensuring the correct departments have assessed the applicable changes.
• Maintaining and updating vendor SOPs
• Aid in the completion of technical agreements
• To assist the Quality department in the overall implementation of the Quality function necessary for the maintenance of the quality management systems and related activities.
• Provide general support to all Quality Unit activities relating to GMP, GCP, and other similar Quality Systems established within the company in order to ensure that the appropriate standards and effective working systems and relationships are maintained and where necessary improved throughout the company.
• To identify and contribute to areas for improvement within the quality management systems to ensure compliant and efficient systems.
• Provide input into the enhancement of quality policies, systems and procedures as appropriate.

The Candidate
• Significant previous QA experience
• Demonstrable experience and sound knowledge of GMP regulations and vendor management.
• Strong follow-up skills and attention to detail
• Ability to work independently
• Competence in both written and verbal communication.
• Ability to interact with personnel at all levels from a variety of disciplines.

25/08/2020

GxP Recruitment invites applications on behalf of our biopharmaceutical client where an excellent opportunity exists for a Computer Systems Validation Specialist to join their team in Wiltshire on a permanent basis.
Job Purpose:
This role within the Validation team is necessary to manage and execute validation activities associated with the cGMP compliance of computerised and software systems, ensuring that they are appropriately qualified and fit for operational use. The role will ensure that the commercial risks associated with disaster recovery and data life cycle compatibility are addressed for each computer system guaranteeing long term availability of business critical systems and data. This role is a hands-on position and requires the post holder to be able balance multiple project based activities, coordinating the generation, review and ex*****on of validation protocols with the relevant stake-holders.
Key duties include:
• Take the lead in computer system validation and compliance, manage and deliver specific Validation Projects according to the business priorities, including work scheduling and supervision of junior members of staff.
• Comfortable working alone or within the matrix management system.
• Continuous improvement of validation systems and procedures to ensure efficiency and best practice within the industry and to stay abreast of changing regulatory expectations.
• Write, review and approve validation documentation including protocols and reports and manage the timely closure of any discrepancies or non-conformities.
• Providing a reliable service to our internal customers to ensure that timescales are met and work is carried out to meet expectations.
• Maintaining the ongoing compliant status of computer systems associated with equipment, facilities and utilities by involvement of the scheduling of activities.
• Communicating validation activities with our internal and external customers and working with them to resolve problems and conflicts.
The ideal candidate:
• Suitability qualified in a relevant field
• Significant experience of generation and review of validation protocols, reports
• Experience of validation life cycle activities for computerised systems
• Work experience within GMP
• Experience dealing with internal customers
• Experience of supervising junior staff
• Comprehensive understanding of EU and FDA regulatory requirements relating to validation incl UK/EU GMP annex 11 and 21 CFR Part11
• Technical understanding of PLCs, SCADA, networked systems, lab systems

25/08/2020

GxP Recruitment invites applications on behalf of our biotech client in Central Belt of Scotland where an excellent opportunity has arisen for a Clinical Research Associate to join their team on a permanent basis.

Job Purpose:

The Clinical Research Associate (CRA) will be responsible for the coordination of a variety of clinical trials in oncology (Cell immunotherapy) to ensure the trial is conducted in accordance with ICH GCP and other relevant regulatory guidelines. The trials will be conducted in the UK and EU.

Job Purpose:

The postholder will take ownership of assigned studies and carry out site selection/feasibility, support to EC/RA submissions, initiations, on-site monitoring, and close-out activities

Key duties include:

• To ensure appropriate attention is provided to the sites in order to drive data quality so that the clinical study protocol requirements are fulfilled within the appropriate regulatory and ethical framework.
• Experience of performing site start up procedures, routine monitoring and site closure.
• Ability to manage multiple priorities across various clinical trials
• Establishing regular lines of communication plus administering protocol and related study training to assigned site
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution

The ideal candidate:

• Life science or nursing degree or educational equivalent or equivalent combination of education, training and experience
• Minimum 2 years’ experience of field-based trial monitoring as a CRA (oncology preferred but other therapy areas would be considered)
• Thorough knowledge of ICH GCP
• Experience in site set up and regulatory and EC submissions in EU and US would be an advantage
• Experience in haematology, immunotherapy and/or cell therapy would be an advantage
• Thorough knowledge of ICH GCP and other industry-recognised standards and guidelines and conducting clinical trials in general.
• Excellent inter-personal, organisational, presentation and written communication skills
• Proactive approach with high levels of initiative, energy and commitment.

24/08/2020

GxP Recruitment invites applications on behalf of our biotechnology client in Lanarkshire, Central Scotland where an excellent opportunity now exists for a QC Technician to join them on a permanent basis.
Job Purpose:
The QC Technician will work across all functions of QC working closely work Analytical, Microbiology and Materials. You will support material receipt and release, final product shipment, sample receipt and released as well as general housekeeping tasks and testing of in process and final products.
Key duties include:
• Ensuring the receipt, control and release of all banked material to GMP standards. Specifically, the management of stock, organisation of testing, and compilation of testing results.
• Responsible for the control, receipt and release of intermediate components to GMP requirements.
• Responsible for arranging shipment of samples to third party testing houses, reporting the results to the relevant staff/departments, and recording the results with the relevant batch.
• Responsible for the release of consumables and raw materials to GMP requirements.
• Responsible for the stock inventory and procurement for Quality Control.
• Performing endotoxin tests, bioburden, plate incubation and environmental monitoring plate reads
• General cell culture and cell counts for in process and final product release.
• Assisting laboratory staff with maintaining a clean, organised and smooth-running working environment.
• Reporting, to the line manager, any deviations occurring during the manufacturing or quality control process and ensure a deviation report is submitted and corrective and preventative actions progressed to completion.
• Preparing and maintaining documentation to appropriate quality standards, including, but not limited to, laboratory notebooks, standard operating procedures, study protocols and reports, TSE evaluations, COSHH/BIOCOSHH assessments and Risk Assessments.

The ideal candidate:

• Degree qualified in a biological science
• Min 2 years experience working to GMP
• Stock level maintenance and monitoring
• Experience in cell culture is desirable but not essential
• MS Office skills
• Excellent attention to detail
• Experience in analytical methods eg pH and endotoxin preferred, but not essential

17/08/2020

GxP Recruitment invites applications on behalf of our biopharmaceutical client based in Wiltshire where an excellent opportunity now exists for an Analytical Scientist/QMS Assistant to join their team on a permanent basis.
Key duties include:
• Employ established analytical methods for the routine analysis of biopharmaceutical materials.
• Tasks will include the operation of HPLC and UPLC systems, utilising a variety of separation chemistries for protein analysis, as well as the use of a range of other biochemical methods such as enzyme activity assays, protein concentration measurement, UV/Vis spectroscopy and gel electrophoresis.
• Take responsibility for the preparation and documentation of reagents and for ensuring that consumables are available.
• Fully document all analytical testing in worksheets associated with standard protocols or in laboratory notebooks.
• Where necessary, help to adapt and apply analytical methods to analyse novel materials or assist in the development and implementation of new analytical methods.
• Write reports as required and assist with the preparation of experimental plans and protocols.
• Establish links and collaborations to benefit the project and/or department.
• Support the management, maintenance, reporting and continuous improvement of the ISO9001:2015 Quality Management System.
• Ensure ongoing compliance with ISO9001:2015.
• Draft quality policies and procedures as required.
• Support the document control system.
• Coordinate and document internal audits, actions and completion of actions.
• Coordinate, support to ensure timely closure of actions raised from internal, external and regulatory auditors; facilitate closure of investigations arising from study discrepancies, customer feedback or other required improvements.
• Conduct internal audits as scheduled reporting and closing actions in a timely manner
• Review and identify areas of improvement within the quality system.
The ideal candidate:
• HND or Degree in Biological Science, Chemistry or similar
• Good understanding and experience of safe working laboratory practices
• General laboratory experience including preparation of reagents
• Knowledge and understanding of a range of techniques for the analysis of proteins and enzymes
• Experience of working to the requirements of a quality system such as ISO9001 or GMP
• Good organisational skills, meticulous and able to meet deadlines

17/08/2020

GxP Recruitment invites applications on behalf of our biopharmaceutical client in Wiltshire where an excellent opportunity exists for an experienced Fermentation Development Lead to join their team on a permanent basis.
Job Purpose:
Key duties include:
• Support the Head of Fermentation Development to manage the activities dedicated to the development of GMP and non-GMP fermentation processes.
• Be responsible for the line management of junior staff including scientific management, performance management, supervision and training.
• To provide expert scientific and technical specialism in the area of Fermentation processing to projects involved in the improvement of existing and development and manufacture of new biopharmaceutical products.
• To act as principal investigator/lead specialist of the project teams taking lead responsibility to deliver key objectives and identify, evaluate and adapt new technologies where appropriate and to ensure that projects operate to a high scientific standard using current methods.
• Play a key role in the technology transfer activities relating to the development and/or manufacture of biopharmaceutical products.
• Assist senior management in developing scientific and technical strategy of the project or derived projects, identifying new opportunities as they arise and responding to funding calls or customer enquiries.
• Take responsibility for the initiation and implementation of research and development activities for new projects within the area of expertise.
• Provide reports as required and lead on preparation of project proposals, presentations, publications and liaison with the customer as well as dealing with enquiries as necessary.
• To critically review internal and external technical documents.
• Prepare project plans, monitor and report progress against agreed timelines as required by Project Managers.
The ideal candidate:
• Ideally higher Degree in relevant scientific discipline. MSc or higher
• Several years relevant laboratory experience of fermentation processes and media development, strain development, scale-up, QbD and DOE
• Participation in multidisciplinary project teams and line management experience
• Technology transfer & Process validation experience
• GMP working knowledge would be highly advantageous
• Proven leadership track record
• Technical writing of project plans, protocols, scientific publications, project reports
• Proven ability to lead projects
• Excellent communication skills

17/08/2020

GxP Recruitment invites applications on behalf of our biopharmaceutical client in Wiltshire where an excellent opportunity has arisen for a Validation Technologist to join their team on a permanent basis.
Job Purpose:
The post holder will be required to write, review and where appropriate approve validation reports prior to ex*****on, followed by report generation. The core activities will include
• Autoclaves (BSEN 285)
• Depyrogenation ovens
• Extraction Tanks
• Centrifuges
• Vessels
And Facilities and utilities.
Key duties include:
• Generate, review (technical) and execute process validation protocols
• Create validation reports
• Using the Electronic Quality Management System (master control) to manage appropriate corrective action plans and report through the non-conformance system, for failures/performance issues.
• Write and review Risk assessments
• Manage work schedule as planned by the validation schedule co-ordinator
• Coordinate Contractor or permanent resources to deliver timely documentation in support of Validation activities
• Ensure Validation procedures are aligned with regulatory requirements
• Meet all internal regulatory training requirements (internal training provided)
The ideal candidate:
• Degree qualified in relevant field
• Previous biopharma-based experience ideally
• BSEN-285 Sterilisation. Steam sterilisers. Large Sterilisers would be beneficial
• Equipment validation
• Understanding of the validation life cycle
• PC literate

16/08/2020

We invite applications on behalf of our biopharmaceutical client in Wiltshire where a new exciting opportunity has now arisen for a Director of Quality to work alongside the Managing Director at site.
The Director of Quality is responsible for directing and implementing strategies across the business to ensure compliance with regulatory requirements, industry standards, and internal procedures that affect the manufacturing and production of biopharmaceutical products. The incumbent will be responsible for internal compliance programs associated with the entire life cycle of product development and manufacturing. The Director of Quality will report to the Managing Director and is accountable for management control quality systems including Audit, Management Review, and Escalation to Management to ensure issues are proactive identified and managed, and that all sites are in constant state of inspection readiness by FDA, Health Canada, MHRA and other appropriate international regulatory bodies. The individual will also be required to play a key role in supporting Quality team members in developing robust compliance with continually improving quality systems and ensuring the delivery of licensed products in a compliant and efficient manner. The individual is expected to be able to regularly synthesize key analytical outputs in management-ready deliverables to help inform and drive strategic business decisions. In addition to strong business acumen, the individual is expected to have a strong grasp of the highly regulated biopharmaceutical industry.
Key duties of the Director of Quality include:
• Ensure GMP and quality system compliance of all products and relevant operations with UK, US and international pharmaceutical GMPs and form a close working relationship with the Managing Director, Company Secretary other Senior Executives and Non Executives.
• Oversee the internal GMP and quality system audit program for all products.
• Design, implement, and administer a management escalation process to ensure appropriate issues are elevated for management awareness and intervention.
• Facilitate the management review process with executive management.
• Ensure the quality and compliance of all required regulatory notifications.
• Communicate with regulatory bodies as necessary and host regulatory inspections, as necessary
• Monitor the external FDA, MHRA and Japanese regulatory landscape to assure internal systems and controls are in line with current practices and approaches to compliance.
• Develop and sustain a high performing team of direct reports, with attention to development and succession planning.
• As a member of the Executive Team, contribute fully to the development of company strategy across all areas of the business, challenging assumptions and decision-making as appropriate and providing Development analysis and guidance on all activities, plans, targets and business drivers.
• To lead and manage the business, via a management team, to secure the delivery of high quality products/services in an effective and timely fashion
• To report on the business and performance of Quality as required to the Board and others.
• To liaise and interact positively with appropriate regulatory authorities.
• To take Executive responsibility for Health and Safety

The ideal candidate profile:
• Significant senior management experience, ideally PhD qualified or equivalent MBA
• Extensive track record of Quality leadership in the pharmaceutical industry
• Proven leadership and managerial skills in a matrix management environment
• Exceptional communication skills at all levels
• An excellent relationship builder, internal and external
• A commercially astute, articulate, technically strong and influential leader able to operate at both strategic and operational levels.
• A comprehensive understanding of the UK and FDA regulatory requirements for biopharmaceutical products and demonstrable understanding of US/MHRA and international GMP.
• An experienced manager of direct reports

Address

Stapeley House, London Road
Congleton
CW57JW

Telephone

01270 897279

Website

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