Quality Assurance Officer - Pharmaceutical
Quality Assurance Officer- Rotating Double Day Shift
Salary up to £40,000 DOE + a healthy shift premium and excellent company benefits to accompany
Based in Cambridge
A leading Pharmaceutical Manufacturer featured in the top 100 companies to work for are now seeking an experienced Quality Assurance Officer.
The main purpose of this role is to support the day-to-day production operations and ensure the effective execution of the company quality system requirements to assure medicinal products are manufactured in accordance with the "Marketing Authorisations" and in compliance with GMP and regulatory requirements.
Our client has a real focus on staff development, ensuring all employees are managed in a way that keeps them motivated and looking for that next promotion.
Standard working hours will follow a double day shift pattern which rotates Monday to Friday each week, with an early and a late shift as follows:
Week 1: Monday to Thursday 06:00 - 14:00 13:45 - 21:45
Friday 06:00 - 12:45 12:30 - 19:15
Week 2: Monday to Thursday 13:45 - 21:45 06:00 - 14:00
Friday 12:30 - 19:15 06:00 - 12:45
Main job responsibilities: -
*Ensure the continuous compliance of production operations to GMP and business requirements
*Proactively identify and support the implementation of Continuous Improvement opportunities within Quality Assurance and Production Operations
*Provides routine support and advice to the Production Department on quality issues
*Ensure the timely communication of significant GMP and/or product quality issues to QA and Production management
*Seek out new opportunities for changes in QA practices
*Help to implement new ways of working within the QA Department
*Identify root causes, perform risk assessments and drive Continuous Improvement and CAPA
*Assist in audits and compliance activities (self-inspections, external audits and regulatory inspections)
*Assist with Quality Management reviews
*Facilitate the approval of product batches through the collation, review and approval of batch documentation to the QP in accordance with the company batch document review system
*Perform the inspection and approval of primary and secondary packaging materials as required
*Assists your Qualified Person in carrying out their duties
*Complies with H&S, GMP and company policies at all times
Working closely with Senior QA Officers and the QP you will need: -
*Knowledge of the Quality Management system processes and GMP as outlined in Directive 2003/94/EC
*Minimum of 2 years QA experience with a Pharmaceutical Quality System
*The ability to resolve standard quality issues within pre-defined parameters for internal customers
*To plan and organise core duties efficiently and effectively.
*To be able to work as a member of a team and adopt a flexible approach to work when required
*A good understanding and can apply GMP as outlined in the Directive 2003/94/EC
*To understand the 2001/83/EC Directive and the relevant ICH guidelines
*To require minimal supervision working within the parameters of the Quality Management System (QMS)
*Experience of self auditing and doing self-inspections
*To be able to undertake: root cause analysis, corrective and preventive actions, change control, quality risk management
*To support Product Quality Defects and Product Recalls
*To demonstrate the fundamental understanding of validation principles
*To be able to draft reports for review by a senior member of the team.
*To be able to review quality documents ranging from batch records, packaging documents and standard operating procedures (SOP's).
*Ideally you will have worked on a shift rota before
*To hold relevant qualifications
For more information and to apply for this position, please send your CV with a covering email to explain why you feel you should be considered for this post.
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Quality Assurance Officer - Pharmaceutical