Site Investigation Lead/ Qualified Person - Watford, United Kingdom - Cpl Life Sciences

Cpl Life Sciences

Verified Company

Watford, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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, datalogger statements, inlicensed 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