Quality Assurance Specialist
The consultants will work with the Quality department to get their batch releases and documentation back on track with the business’ schedule.
Key Areas of accountability/responsibility
• Responsible for final disposition to customers of cell banks and bulk pharmaceutical products and
for managing all activities to enable this disposition in an efficient and cGMP compliant way
according the agreements made with the project manager, the client and according to regulatory
expectations. Proposes and implements improvements related to quality and compliance.
• Advise to project organization and customers on all relevant cGMP matters and assure appropriate
cGMP level of project activities.
• Serves as quality advisor for investigations and recommends actions to ensure continued
compliance and avoiding recurrence.
• Reviews and approves cGMP documents associated to the product in compliance with local and
corporate SOPs and applicable legislation.
• Approves investigations assuring that they are complete, accurate, technically justified with the
required documented evidence including risk assessment.
• Review and approval of Process and Product Validation and Qualification Reports.
• Review and approval of Testing Validation and Qualification Reports.
• Perform the investigation of Product Complaints and Recalls.
• Evaluates and approves Changes associated with the product.
• Plan, perform and monitor in collaboration with the project manager QA activities within the
project to ensure results are according the agreement and regulatory expectations.
• Provides assistance and guidance with regard to the Quality Systems to other departments.
Proposes and implements improvements to these systems.
• Execution of internal audits.
Please apply now for more information!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
South West England
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