Reference Number: JO-2306-518646
Job Type: Permanent
Almost 100% virtual role, only expected in Hatfield approx. 1 per quarter.
Must be UK qualified QP.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
The Role & What You Will Be Doing
· To carry out the duties and responsibilities of a Qualified Person as detailed in EU Directive 2001/83/EC and 2003/94/EC.
· To ensure the principles and responsibilities of GMP and GDP, as stated in MHRA’s Rules and Guidance for Pharmaceutical Manufacturers and Distributors are interpreted and implemented correctly.
· Participate in and manage the following quality systems.
· Batch documentation review and subsequent batch disposition, including certification for release.
· Sampling, inspection, batch processing and approval of bought-in products.
· Liaison with contract laboratories and review of data generated following analysis.
· Investigations into customer complaints.
· Management of recalls of pharmaceutical products for the market.
· Internal and external inspection programmes and to represent the department during regulatory inspections.
· Review and processing of expired inventory, returns and rejects.
· Maintain communication with third party warehouse, suppliers and line management.
· To advise on activities relating to product quality ensuring compliance with registered particulars, GMP/GDP, and ensure supply issues are resolved in a timely manner and maintain stock levels.
· Represent the department in new product introduction and product transfer processes and to provide comment on associated validation work.
· Maintain communication with line management.
· Aid in the training and mentoring colleagues in all aspects of GMP and other areas, as appropriate.
· Business travel as required for technical meetings and project initiatives.
· Meet annual objectives as agreed and carry out any other duties as directed by the Quality Vertical and UK Affiliate.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
· BSc and or MSc in relevant scientific field
· Eligible to act as a Qualified Person for the certification of marketed products in accordance with UK legislation
· Excellent verbal and written communication skills with the ability to work independently and within dynamic / collaborative cross-functional team environments
· Experience with communicating with the MHRA
· Experience with various IT systems such as SAP, Documentum, Trackwise
· Knowledge of manufacturing and packaging documentation, change control, qualification and validation process
· Good decision-making skills, flexible to current and new situations