I have an exciting opportunity for a Qualified Person (QP) to join one of the leading Blue-Chip Pharmaceutical companies at their Head Office. You will be responsible for the Quality oversight of the supply of consumer products from manufacturing sites into the UK and Ireland warehouses.
The portfolio of products includes medicines, medical devices and cosmetics. For medicines, this specifically includes performing duties and obligations of QP in accordance with Annex 16, cGMP Requirements and Directive 2001/83/EC for the UK.
Main Duties & Responsibilities
The Qualified Person will be responsible for certification of finished product batches and release in accordance with UK and EU regulatory requirements and confirming compliance of intermediate stages of manufacturing.
Qualified Person Key Responsibilities include:
- To lead batch assessment and release activities to ensure releases are carried out efficiently, in a timely manner, and meeting relevant regulatory standards.
- Perform Qualified Person certification and associated placement on the market through the CERPs system for UK market.
- Accountable for review and approval of Quality Agreements and liaison with manufacturing sites to ensure compliance to local registered technical details (in connection with local regulatory team), including Distribution Risk Assessments for products supplied from manufacturing site to market.
- Liaison with Contract Manufacturer Organisation (CMO) Quality for products that are manufactured by contractors to ensure compliance to local registered technical details (in connection with local regulatory team).
- Investigate and resolve Quality-related issues arising from the deliveries with Area Quality Lead, Logistic Services Provider (LSPs) and supplying sites.
- Manage temperature excursions from deliveries from supplying sites to local UK warehouse.
- Perform all quality activities into CERPS and GMM as appropriate
- Provide oversight on positive release process for cosmetic products with the local warehouse and manufacturing site as necessary.
- Provide oversight on local Repacking.
- Support relevant quality processes including deviations, CAPA, Self Inspection, Change Control, Management
- At least a BSc or equivalent in a life sciences discipline, chemistry, or biochemical engineering, though an MSc in a Life Sciences discipline is ideal.
- 7 years hands-on experience gained in both Quality Assurance and Quality Control departments with at least 3 years in a Supervisory position.
- Qualified Person (under permanent provisions).
- 5 years hands-on experience gained in both Quality Assurance and Quality Control departments.
- Thorough knowledge of cGMP guidelines gained through practical experience of supporting cGMP manufacturing operations.
- Extensive experience of Internal & External Quality auditing, CAPA management, deviation management & risk assessments. Preparation for FDA and EMA inspections.
- Knowledge of biotech and aseptic manufacturing and processes, and product testing methods.
- Familiarity with LIMS, EQMS (Trackwise), EDMS (Documentum) and EBR (Syncade) or equivalent Quality systems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.