GCLP QA Manager

A trail blazing and fast paced company are looking for a GCLP Quality Assurance Manager to join their team in London. This organisation is dedicated to developing new products, this role is for an innovative QA Manager who will thrive on making things happen.

Job Responsibilities

• Perform routine QA duties to ensure GCLP compliance plus other regulatory requirements relating to oversight of clinical laboratory activities for cellular therapies and ATIMPs.
• Review and approval of documentation including but not limited to Standard Operating Procedures (SOPs), policies and forms, ensuring compliant templates used (as required), considering usability, accuracy, consistency and quality.
• QA support for GCLP associated Quality System Documents such as but not limited to Change Controls, Deviations, Root Cause Investigations and Corrective and Preventative Actions (CAPAs).
• Verify completion of actions from Quality System Documents such as Change Controls, Deviations, Investigations, CAPAs, Audits and update relevant Quality Logs, as required.
• QA support for GCLP assay activities (qualification & validation) according to regulatory guidelines.
• QA support for laboratory set up and transfer including equipment qualification activities, as required.
• Implementing or improving processes used in the GCLP laboratories.
• QA review of GCLP laboratory worksheets and reports, as required.
• Perform internal and external audits relating to GCLP activities.

Skills and Requirements

• Scientific Degree - B.Sc. or M.Sc. or equivalent in Biochemistry, Biology, Biomedical Sciences or Pharmacy or closely related subject.
• Minimum of 5 years' experience in developing and maintaining fit for purpose quality systems.
• 5 years' experience working in a GCLP or GLP environment or equivalent experience.
• Experience with laboratory equipment qualification and assay validation activities.
• Technical expertise/knowledge of quality requirements for laboratory techniques.
• Able to lead and build a document management system, writing/supporting SOPs and plans to formulate complete GxP "ground systems" for Translational Science laboratory operations.
• Experience in planning, managing and executing vendor and site audits.
• Experience of working with contract research organisations;
• English Language skills;
• Good working knowledge of using Microsoft Office programs;

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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