ROLE OVERVIEW
We are currently looking for a Validation Specialist (Manufacturing Support) to join a leading pharmaceutical company based in the Leicestershire area. As the Validation Specialist (Manufacturing Support), you will be responsible for product and process validation, owning PPQ campaigns, and ensuring robust CPV for commercial products at our Charnwood site. You will ensure processes remain in a validated state and inspection-ready at all times, partnering closely with Manufacturing Operations and the wider Technical Operations Group to turn science and data into compliant, reliable supply and support investigations where required.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Specialist (Manufacturing Support) will be varied however the key duties and responsibilities are as follows:
1. Lead PPQ: Author/approve protocols, define sampling plans and acceptance criteria, oversee execution, analyse data, and issue PPQ summary reports for timely release.
2. Lead or participate in equipment and facility qualification: Deliver qualification lifecycle for GMP relevant equipment using DQ–IQ–OQ-PQ and maintain equipment in a validated state through periodic review and scheduled requalification.
3. Lead or participate in new technology and/or process selection.
4. With Technical Operations and Quality, generate URS, review and approve functional/technical specifications, Quality Risk Assessment, Traceability Matrix, IQ/OQ protocols and summary reports.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Validation Specialist (Manufacturing Support) we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Science or Engineering subject.
2. Proven industry experience in process validation in GMP drug product (OSD), including PPQ leadership and CPV.
3. A working knowledge and practical experience with regulatory guidelines such as FDA 2011 PV, EU GMP Annex 15, and ICH Q8/Q9/Q10.
Key Words:
Validation Specialist / Manufacturing Support / Pharmaceutical Development / Leicestershire / GMP / PPQ / CPV / Equipment Qualification / Process Validation / Regulatory Compliance / Quality Systems / Lean Manufacturing / #LI-DNI
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.