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Quality Assurance Specialist
2 weeks ago
We are seeking a diligent and experienced professional to join our Quality team as a Qualified Person.
- The role requires oversight of business activities relating to contract manufacturers, suppliers, and technical due diligence activities.
The Qualified Person will be responsible for executing the legal duties defined under Directives 2001/83/EC and 2001/20/EC, in compliance with EudraLex Vol. 4 Annex 16 and Annex 13, the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (the Orange Guide) as published by the MHRA, and any other applicable laws, guidelines, or regulations.
- To ensure that manufacturing activities at assigned CMOs are appropriately managed in accordance with EU GMP under directive 2003/94/EC and in compliance with EudraLex Vol. 4 Annex 16 and EudraLex Vol. 4 Annex 13, the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide) as published by the MHRA and any other applicable rule, guideline, and legislation (or equivalent standards for overseas facilities).
- To ensure that manufacturing activities relating to CTS services for IMPs manufactured and packed at overseas partner facilities are conducted in accordance with equivalent standards to those required by EU GMP.
- To ensure that operations do not compromise the quality of medicines.
- To ensure that adequate records are maintained relating to the legal duties of the QP.
- To participate in the audit of the Clinigen quality system and to carry out independent audits of marketing authorisation holders necessary suppliers and partner facilities and processes.
- To ensure that appropriate standards of GDP and GMP are maintained.
- To employ due diligence in the discharge of his/her duties and to report to senior management and the MHRA any suspicious events of which he/she becomes aware.
- To be named on site MIA licenses (currently MIA(IMP) only) and perform the legal duties of the QP in accordance with directives 2001/83/EC and 2001/20/EC and in compliance with EudraLex Vol. 4 Annex 16 and EudraLex Vol. 4 Annex 13, the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide) as published by the MHRA and any other applicable rule, guideline, and legislation when called upon to do so.
The ideal candidate should possess:
- Eligibility to act as a QP under directive 2001/83/EC (preferably under the permanent provisions).
- Experience in aseptically produced sterile products and ideally lyophilized dosage form.
- Ideal experience of QP certification for release of clinical trial materials under directive 2001/20/EC inclusive of dosage form manufacturing and clinical packing.
- Demonstrable business and commercial awareness combined with patient focus.
- Experience of working independently and as part of a team.
- Experience of working across multiple time zones and in global business cultures (particularly US and Japan).
The successful candidate will have the opportunity to work with a rapidly growing global specialty pharmaceutical services business, with a unique combination of services across the pharmaceutical lifecycle.
About UsWe are a dynamic and collaborative organization, committed to delivering high-quality services to our clients. We offer a supportive and stimulating work environment, with opportunities for professional growth and development.
