We are working exclusively on a confidential basis with a pharmaceutical company based in the Midlands. We have a new appointment for a Senior Quality Manager with managerial & leadership capabilities to manage both a QA & QC division. This position will be a Hybrid based position. This person will have responsibilities such as design, maintain and coordinate site Quality system which ensures appropriate levels of quality and GMP compliance to assure GMP License to Operate (LTO), and that Finished Products provided to the market are as per company specification and in compliance with applicable quality requirements and customer expectations
Key Individual Accountabilities:
- You will own the Release of product, approval of quality documents, Q aspects of MoC, investigations and CAPA’s, stability studies, qualification of raw materials.
- Influences: Timely update and review of documents, SOP’s, protocols, investigations etc.
- Prepare and update SOPS/documents of Quality Assurance.
- Follow up CAPA and to monitor the actions taken are routinely followed and becomes part of system.
- Review batch records for compliance and ensure complaint release of products to market Qualified Person
- Host and actively participate in external audits and authority inspections performed at site.
- Timely prepare corrective and preventive action plan for the external audits/inspections
- Ensure that annual internal audit plan is prepared and followed throughout the year.
- Perform vendor audits of raw & packaging materials.
- Manage SLA with external third party vendors
- Ensure validation & revalidation activities are performed as per the plan/schedule.
- Review validation/revalidation documents.
- Review deviations raised on site.
- Review investigation reports of market complaints, deviations, OOS etc.
Key Shared: Accountabilities:
- Ensure that activities carried out at the site are meeting the cGMP requirements and that the guidelines are being followed.
- Ensure that only properly trained personnel are involved in the storage / production / quarantining and analysis of a product.
- Ensure qualified instruments and equipment are used for manufacturing, testing & storage of products.
- Take active part in global activities with the aim of better practice sharing and alignment globally
Experience & Qualifications Required:
- Minimum 8 years of relevant experience in pharmaceutical industry in a FDF plant/site
- Experience with managing both QA and QC functions
- Pharmacist or Chemical Engineering background
- Lean Six Sigma green or black belt is a plus
- Qualified Person would be desired
- In depth knowledge of c-GMP.
- In depth understanding of FDF manufacturing and regulatory requirements
- Both QA and QC understanding
- Good communication and interpersonal skills.
- Adapting and responding to changes.
- Team oriented with a high level of psychological safety in his/her leadership
For further information on this opportunity or a confidential discussion please reach out directly to Gillian Nicholson at email@example.com