Qualified Person

Walker Cole International is supporting a well-established pharmaceutical manufacturer in the UK in the search for a Qualified Person to join its growing Quality team.

This is an excellent opportunity to join a business manufacturing both commercial and investigational medicinal products, where you'll work alongside an experienced QP team and play a key role in ensuring the compliant release of medicines supplied to patients across global markets.

Key responsibilities for the QP include:

• Certifying commercial and investigational medicinal products in line with Marketing Authorisations, Product Specification Files and IMPDs.
• Providing Quality oversight across manufacturing, packaging, deviations, change controls and investigations.
• Working closely with Manufacturing, QC, Supply Chain and Regulatory teams to support compliant product release.
• Supporting inspection readiness and driving continuous improvement across the site's Quality Management System.

To be considered for the QP role, you should have:

• Eligibility to act as a Qualified Person
• Previous experience certifying pharmaceutical products within a GMP manufacturing environment.
• Strong knowledge of UK and EU GMP and pharmaceutical regulatory requirements.
• Experience supporting Oral Solid Dosage and/or non-sterile liquid manufacturing for clinical or commercial supply.

Qualified Person | QP | Batch Certification | Batch Release | EU GMP | Annex 16 | IMP | Investigational Medicinal Products | Commercial Manufacturing | Oral Solid Dosage | OSD | Non-Sterile Liquids | Quality Assurance | Pharmaceutical Manufacturing | Quality Management System | QMS | GMP Compliance | Deviations | CAPA | Change Control | Risk Management | Product Quality Review | PQR | Audit Readiness | Inspection Readiness | Marketing Authorisations | IMPD | Pharmaceutical Packaging | Clinical Supply | Commercial Supply | Root Cause Analysis | Cross Functional | Continuous Improvement | Manufacturing | Quality Oversight | MHRA | QA | GMP | Pharmaceutical Industry

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