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Quality Auditor

U306

We currently has a requirement for a Quality Auditor for a 12 month contract based in Hoddesdon.

Category:
Control Quality
Location:
United Kingdom
Years of Experience Req.:
Proven qualifications and experience
Date Posted:
19/06/2020
Days Remaining:
60
Employment Type:
Contract
Education Level Req.:
Proven qualifications and experience

 

The main purpose of the role will be to support the Quality Assurance activities within Global Development Quality (GDQ), a department within the Company's Research and Development Organisation. GDQ is responsible for Quality Oversight of R&D manufacturing and testing activities and supporting release of Investigational Medicinal products for Our Company's entire clinical trial portfolio worldwide.

Responsibilities

Completes audits to ensure compliance to SOPs, GMPs and applicable regulations.

Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.

Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.

Support product recalls and stock recoveries as appropriate.

Identify compliance gaps and make recommendations for continuous improvement.

Creates and maintains assigned SOPs.

Perform and review complaints and deviation investigations, change controls and CAPA’s.

Assists in the induction process for new starters and training of other staff.

Generally, follows standard procedures and consults with manager/supervisor to ensure resolution of exceptions.

Compiles data for reports and presentations, provides data interpretation draws conclusions.

Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.

Keeps abreast of cGMP requirements as described in applicable worldwide regulations.

Represents department on cross functional teams.

Additional activities as assigned by the manager/supervisor

Qualifications & Experience

Bachelor’s degree (or higher) in an Engineering or Science discipline.

At least one-year experience in the Pharmaceutical\Biotechnology industry, with a working knowledge of GMP.

Demonstrated ability to work independently and to drive the completion of tasks.

Team player, learning from and helping others overcome obstacles.

Effective communication, negotiation, problem-solving, and interpersonal skills are necessary to perform job responsibilities.

 

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