Site Investigation Lead/ Qualified Person

4 weeks ago

Watford, United Kingdom Cpl Life Sciences Full time

Cpl Life Sciences are actively recruiting for a Qualified Person/ Site Investigation Lead to join an exciting and reputable Pharma company and leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity)with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India.

The role of the Qualified Person is required to act in compliance with the legal responsibilities and routine duties as defined by EU Directives and Local Law with regards to dispositioning of batches for the UK and supporting with QP related activities.
- Key Responsibilities:
To act as a Qualified Person in accordance with EU/UK GMP to provide final certification/batch dispositioning to the UK market in good co-operation with the BMS testing and disposition co-ordinator to assure timely dispositioning.
- To review and approve relevant quality documents under which: change control request, technical agreements, analytical method transfers, NCRs, PQRs, SCs, APQRs, risk assessments, data-logger statements, in-licensed master batch records from partners / manufacturingsites in compliance with marketing authorisations.
- To review and provide support and final assessment of OOX investigations from client and contract laboratories
- To provide QP GMP declarations in support of importation activities on Marketing Authorisations.
- Support the EU QMS group to ensure a state of compliance for the client
- EU wide
- To function as lead auditor for internal and external audits
- Function as lead host for MHRA inspections and customer audits
- Handle specific issues as: (potential) recalls for products.
- Act as hierarchical supervisor of the QP support officer
- Key Requirements:
Scientific degree (pharmacy, microbiology, chemistry) eligible to act as UK Qualified person (2001/83/EC)
- Previous experience as a QP for OSD (Oral Solid Dosage Form) and OLD (Oral Liquid Dose Form) and SSD (Semi Solid Dosage form), and Inhalers
- Wide experience of a Quality role in a pharmaceutical company
- Auditing experience -GMP/ICHQ7A/ISO9000/PS9000
- Experience, knowledge, judgment and confidence to make decisions when faced with ambiguity
- Must be able to operate calmly and effectively under the typical pressures of such a role
- Analytical thinking, able to see cause and issues and clearly identify solutions and way forward
- Knowledge of pharmaceutical development process

The Technical Operations team at Cpl Life Sciences (previously Clinical Professionals) is a specialist division that focuses exclusively on the recruitment of Quality Assurance, Scientific and Engineering for pharmaceutical companies, medical device companies,biotechnology companies, Clinical Research Organisations (CROs) and Regulatory Authorities

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