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QA Auditor Compliance Manager

Website Achieva Group Limited

An excellent opportunity has arisen to join a leading pharmaceutical company as a QA Auditor Compliance Manager.

Job Responsibilities:
• Ensure GMP/GDP compliance at third party service providers and within internal facilities
• Lead in establishing external QA Audit and internal self-inspection annual Plan
• Conduct GMP/GDP audit and self-inspections and coordinate with internal personnel and suppliers to schedule, execute and follow up with audit observations
• Promptly report critical self-inspection findings to the Responsible Person and Management
• Create, implement, maintain, and work with Vendors on establishing Quality Agreements where needed.
• Interface between quality/regulatory/compliance personnel and operations to identify applicable regulatory and compliance requirements and ensure accurate understanding of those requirements.
• Manage, review and approve change controls, deviations and CAPAs related to the internal pharmaceutical operations facilities (not project specific)
• Write, review, and/or approve internal SOPs governing compliance related operations and other GMP/GDP and regulatory related documentation

Requirements:
• University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum
• Minimum 3 years experience in Auditing, 1 as Lead Auditor
• Knowledge and understanding of drug product development, manufacturing processes, as well as quality control, packaging and distribution aspects
• Excellent knowledge of relevant GMP/GDP and international quality regulations e.g. ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4), EU GDP and ability to interpret and implement quality standards
• Ability to work on multiple projects with various disciplines and to manage complex projects and prioritize workloads according to the project importance

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