Job Title:  QA Associate Release Team

Role Details

Quality Assurance Associate (Release Team)

Role: Full-time, permanent

Location: Barnstaple, North Devon 

Salary: Competitive + bonus + benefits

The Role

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 Quality Assurance Department

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.

Purpose of the Role:

The following activities will be performed thereby ensuring Product Quality, GMP and patient safety is maintained to an appropriate standard for the products supplied to the market and regulatory compliance commitments are met;

• 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

The Person

Essential:

• 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

Desirable:

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

The Rewards

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.

How to Apply

If you possess the experience, passion and ability to make this role a success then we would like to hear from you. Please complete your Candidate Profile on our careers site to apply for this role. For more information, you can contact us on: careers@accord-healthcare.com

A Bit About Us

Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide. 

To continue our growth, we’re looking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do, we offer rewarding opportunities for those looking for continued personal and professional growth, investing in training and development tailored to each individual’s focus. So, if you’re looking for an inclusive company to take your career to the next level, you’re certainly in the right place; come and join us to make it better.

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

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