Reference Number: JO-2105-467799
Job Type: Permanent
Lead Qualified Person (QP) Line management opportunity.
As the Lead QP, you will hold a senior and highly visible role within the European QA team, with responsibility for providing QA expertise and ensuring compliance for all Quality activities (GxP).
You will have line management responsibility for one member of staff and will be responsible for approving and releasing batches of products to the UK market. Products will mainly be non-sterile generics (tablets, creams, powders) but will also involve some steriles and inhalation products too.
In addition to release activities, you will:
Play a lead role in hosting inspections and audits you will be the Lead Auditor for both internal and external audits.
Review & approve all quality documentation including in-licensed batch records, technical agreements, PQRs, APQRs and risk assessments.
Work closely with the UK QA team, as well as Global manufacturing sites and other QPs and RPs across Europe to ensure timely release of batches.
When applying for this role, please ensure that youre able to demonstrate the following requirements Applicants without these will unfortunately not be considered further:
Eligibility to act as a UK QP, with proven experience as an established QP.
Experience of releasing non-sterile products experience with generics or other dosage forms will also be advantageous.
Line management experience this isnt essential but would be desirable.
A strong track record of Quality Assurance within a GMP environment in the pharmaceutical industry to include auditing experience.
To apply for this role, please call Natalie Robson at CPL Life Sciences on 0118 952 2792 or email email@example.com
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