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QA Technical Specialist

Just Life Sciences are seeking a Technical/Quality Assurance Professional for their Global Pharma Client who are expanding rapidly through acquisition and organic growth.
We are looking for a candidate who has several years experience within a Technical QA role within a Pharmaceutical organisation.

Purpose of the role is

 To provide technical Quality support to the Operational departments for new and ongoing projects.
 Play a lead role in the interpretation of business and regulatory guidelines which assists with regulatory compliance.
 To promote a sense of quality throughout the site business units so as to raise manufacturing/ development/clinical performance and eliminate waste caused by unnecessary compliance errors.
 To conduct performance audits and follow up on actions within site business units.
 Review and approve, for all areas, Master Batch Records (MBR), master despatch job cards, Technical specifications and addendums, master label approvals, returned Technical Specifications and Technical Agreements.
 Write and review Drug Product Files (DPFs), Product Specification Files (PSFs)
 QA approval of Item Masters.
 Batch record compilation and regulatory checks.
 Interpret PQR data.
 Review and approve Deviations and Change Controls as needed.
 To review non-compliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate product quality decisions (in association with site QP’s), and to initiate and promote quality improvements to prevent re-occurrence.
 To ensure that products proposed for release by a site QP were manufactured in accordance with license requirements, clinical trial application and cGMP.
 To assist with GMP training within the department and cross site.

Continuous Improvement
• Review and improve departmental processes and eliminate waste.
General/Other duties
• To identify self-development needs for future performance
• To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities.

Qualifications, Skills and Experience

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