- Management and maintenance of the QMS
- Management of other QA related documentation including annual PQRs, CAPA processing etc.
- Internal QA auditing and working with external contract manufacturing organisations (CMOs)
- Excellent career prospects including training and involvement in Drug Safety / Pharmacovigilance
- North London / Hertfordshire border based close to tube and bus routes
- Smaller, friendly and supportive global pharmaceutical organisation
Summary
Based in the North London / Hertfordshire border area this is a great opportunity for a graduate with experience in a pharmaceutical Quality Assurance documentation setting. Central to the role is the management and maintenance of the QMS while working with the full range of QA related documentation compilation of Product Quality Reviews (PQRs), CAPA processing, QA reports, SOPs etc. plus internal auditing. The company outsource all product manufacturing and this is a non-operational role working with external vendors. The position offers excellent opportunities including training and involvement in drug safety / pharmacovigilance processes. This is an excellent opportunity to develop your QA documentation experience plus gain new Drug Safety skills in a small, friendly and supportive pharmaceutical organisation.
The Company:
The company is a global organisation, headquartered in the UK, specialising in veterinary pharmaceutical products, predominantly for livestock animals. As the animals treated can enter the human food chain all products have full pharmaceutical licenses. The company is well established and growing with over 20 years’ experience holding over 600 marketing authorisations in over 50 countries. It has a strong pipeline of new products in development and clinical trials. The organisation operates as a “virtual company” with a global network of partners and outsourced service providers. As opposed to a “big pharma” company 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 the small, dedicated Quality Assurance team providing support for the Quality standards and Pharmacovigilance unit. With a strong focus on managing on the QMS and Quality Documentation the role involves interfacing with external third-party manufacturing vendors (CMOs) and US based colleagues. Specific 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.
- CAPA processing and resultant SOP reviews and updates.
- Participate in the internal audit programme.
- Maintain other QA related documentation including clinical study protocols, SOPs, reports, batch records 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, SOPs, training etc.
- Ensure GMP and GDP quality standards in a non-operational environment.
- With experience take overall responsibility for defined QA and Pharmacovigilance functions and participate in external vendor audits
Experience
We are seeking an enthusiastic Life Sciences graduate with 2 years (or more) post-graduate commercial pharmaceutical QA documentation experience gained in a non-operational environment that includes responsibility for the QMS. You will have need skills in MS Office backed with strong organisational, planning, attention to detail and communication abilities.
Keywords: QMS and Compliance Specialist, QMS Quality Specialist, QA Doc Controller, QA Documentation Manager, QA Documentation Administrator, Quality Assurance, QA, QA Officer, QA Administrator, QA Associate, QA Assistant, QA Admin, Good Manufacturing Practice, GMP, cGMP, Good Distribution Practice, GDP, North London, Hertfordshire, Herts