Validation Manager - Sterile / Aseptic Manufacturing
Pharmaceuticals / Biopharmaceuticals / Medical Devices
The Validation Manager is responsible for the development and implementation of the strategies for the qualification or the manufacturing unit and equipment including compliance to GMP, specifically Eudralex Annex 11 & 15 and relevant FDA guidance for industry.
Main areas of responsibility:
- Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required.
- Close liaison with the building contractors, engineers and vendors of facility and equipment items to ensure full and appropriate information is provided, along with vendor qualification protocols.
- Support FATS, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.
- Responsible for the oversight of ongoing (DQ, IQ, OQ, PQ) validation activities once production has commenced.
- Review of vendor protocols and creation or approval of in-house protocols and reports to deliver a complete package of qualification documentation.
- As some validation activities will be outsourced, you will maintain these relationships, monitoring KPIs so that performance and value for money is maintained.
- Draft and review GMP documentation including validation documentation, SOPs, and training documentation.
- Participate in and respond to inspections by Regulatory Authorities including MHRA and FDA, representing the validation function.
- Participate in continuous improvement in the manufacturing facility to enable production effectively and efficiently.
- Establish and maintain strong relationships with cross functional departments including Manufacturing, CMC, Engineering and Regulatory groups.
Qualification / Experience required:
- Degree or equivalent in biological science, engineering or related area.
- At least 5 years’ of leading and conducting validation activities in a GMP licensed facility that includes aseptic and/or sterile manufacturing.
- Proven experience of manufacturing compliance to GMP regulations and guidance including specifically Annex 11 & 15. Current working knowledge of GMP, and with a deep understanding of validation of cleanroom manufacturing environments and related equipment
- Experience of participating in the introduction of new processes and equipment into a GMP manufacturing facility.
If you are interested in this role, please click apply now!
Harris Lord is acting as an employment agency for this role.
Keywords: pharmaceuticals, biopharma, biopharmaceuticals, medical device, sterile, aseptic, validation, clean room, GAMP, IQ, OQ, PQ, Annex, GMP, FDA, DQ
- Aseptic Technique