QA Associate Release Team

Quality Assurance Associate (Release Team)

Role: Full-time, permanent
Location: Barnstaple, North Devon
Salary: Competitive + bonus + benefits

To work within the QA Operations function to provide efficient and accurate review of batch documentation, ensuring all batches are manufactured in accordance with the Marketing Authorisation and GMP.

The QA Department has the responsibility for managing key elements of the Pharmaceutical Quality System (PQS) and monitoring its effectiveness, for example through performing self-inspections, investigating customer complaints, reviewing batch records, reviewing deviation investigations, initiating/following up on corrective and preventative actions and reviewing and approving quality critical changes.

The QA department is also responsible for the control and issue of Standard Operating Procedures, maintenance of the Site Master File, the assessment and approval of validation exercises and the review/approval of validation documentation.

The department must ensure that both QA regulatory (EU, US and other third country as appropriate) and business requirements are met at all times for products where Accord is the Marketing Authorisation/ Product Authorisation holder and for products distributed in the UK in Accord livery under an Accord MA or another customer’s Marketing Authorisation.

The department is also the Primary contact during regulatory inspections and customer audits.

• Conducting the review of all batch manufacturing and batch packaging records, including relevant packaging components samples prior to product release, therefore ensuring all batches are manufactured according to the Marketing Authorisation and GMP.
• To highlight any potential quality issues to the Qualified Person prior to product release
• To identify documentation errors and/or discrepancies and ensure resolution of such prior to product release.
• To ensure critical GMP documents are completed accurately, and subsequently logged onto the appropriate database, e.g. QMNs, DCRs.
• To support the timely close out of deviations and follow up on corrective and preventative actions as appropriate.
• To be able to provide support during self-inspections as required.
• To be able to perform spot checks as required.
• Providing support during cross functional investigations / projects as required.
• To perform other duties to support the QA Operations and Systems teams and the QA Documentation / Training team as appropriate.
• Support and maintain Environmental Health and Safety and Business Continuity requirements as applicable to the QA Department

• GCSEs in Maths, English and a Science discipline
• Suitable experience of working in quality based role in the Pharmaceutical Industry (or working within a role involving pharmaceutical GMP), or equivalent experience in the food industry
• Understanding of solid dose manufacture
• Awareness of EU quality related pharmaceutical regulations
• Attention to detail
• Good communication skills
• Good keyboard skills and basic computer literacy
• Able to work well under pressure and react quickly to changing priorities

• Experience in dealing with customers
• Experience of working in a manufacturing and/or quality control environment within the pharmaceutical industry

In return, we offer a competitive salary and rewards package (including holiday, bonus and pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach.

All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.