Qualified Person

Overview

Reference Number: JO-2306-518646
Qualified Person
Rate: Negotiable
Job Type: Permanent
Location: Hatfield

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