Based in North London, on the Hertfordshire border, this is a career enhancing opportunity with a small, globally operating, pharmaceutical company for an experienced QA professional with strong quality related documentation expertise which focusses on the QMS. The position involves managing the full range of QA related documentation including the QMS, Product Quality Reviews (PQRs), CAPA tracking, QA reports, SOPs etc. This is a “non-operational” role working with external vendors in a “virtual” company environment.
Of note: training will be provided in the processing of drug safety / pharmacovigilance reports as these are the responsibility of the QA department.
The Company:
The company operates globally and is headquartered in the UK. They specialise in veterinary pharmaceutical products, predominantly for livestock animals. As the animals treated enter the human food chain all products have full pharmaceutical licenses. The company is well established holding over 600 marketing authorisations in over 50 countries. The organisation operates as a “virtual company” with a global network of partner outsourced service providers. As opposed to “big pharma” the company offers a small, friendly, collaborative and supportive working environment where achievement is recognised and rewarded.
This is a permanent position offering a competitive salary and comprehensive benefits package plus secure parking and is next-door to an underground station and on major bus routes.
The Role
The successful candidate will join a small Quality Assurance team responsible for company-wide quality standards as processing drug safety/pharmacovigilance reports. The role focuses on managing Quality Documentation in a “non-operational” environment interfacing with external third-party manufacturing vendors (CMOs). Responsibilities will include:
- Management and maintenance of the Quality Management System (QMS)
- Compilation of annual Product Quality Reviews (PQRs).
- Set up and maintain Ongoing Stability files and assist in preparation of annual stability reports.
- Preparation of Certificates of Analysis.
- Tracking CAPA processing and resultant SOP reviews and updates.
- Participation in the internal audit programme.
- Maintain other QA related documentation including clinical study protocols, SOPs, QA reports etc.
- Assist in the maintenance and administration of the Pharmacovigilance (Drug Safety) processes for Adverse Events / Serious Adverse Events (AE/SAE) including preparation of PSURs (training will be provided).
- Ensure GMP and GDP quality standards.
- With experience take overall responsibility for defined QA and Pharmacovigilance functions and participate in external vendor audits
Experience
We are seeking a graduate with an absolute minimum of 2 years commercial pharmaceutical QA experience where QA documentation, including the QMS, is a key focus preferably gained in a non-operational environment. This will encompass cGMP and/or GDP (distribution) regulatory standards. This experience could have been gained as a QA Documentation Specialist / QMS Specialist or in a QA Administration role. You will have skills in MS Office with strong organisational, attention to detail and communication abilities.
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