Company: Advanced Clinical Recruitment Ltd
Closing Date: 18 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary, Package and FULL Relocation
A well known and exciting Global Pharmaceutical client of mine is actively looking to add a Quality Assurance Manager to their team, with a focus on External Operations, based in Munich! The role will offer the ideal candidate the chance to work as the single point of contact for all quality related activities at the assigned Contract Manufacturing Organizations. This means we need a professional with fantastic Quality expertise and relationship building skills.
• Acts as Single Point of Contact for all quality related activities at the assigned Contract Manufacturing Organizations (CMO) sites
• Responsible to ensure that QA activities at BTDM Third Parties are correctly managed and ensure that defined processes are adhered to
• Manage, support and supervise assigned CMO sites with respect to implementation and maintenance of local Quality Management Systems and with regard to provision of adequate resources and performance monitoring
• Responsible to ensure that the resolution of quality and technical problems at assigned CMO sites is consistent with company global standards.
• Ensures all aspects of Quality Management of the assigned CMO sites is carried out according to the standards defined, and is regularly monitored and assessed for adequacy of performance (KPI reporting).
• Assesses and ensures assigned CMO sites maintain a state of constant readiness for HA inspections (PAI, directed, other)
• Execute, implement and maintains a Quality Risk Management program
• Provides QA representation and Quality accountability on External Supplier Relation management Team (SRT)
• Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
• 6 years of experience in manufacturing of biopharmaceuticals drug product and Quality Assurance
• Operational knowledge of aseptic processing and packaging operations is a plus
• Experience managing third party manufacturer is desired
• English fluent in speaking / writing, German and/or French desirable. Any other language a plus
• Strong communication skills
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley - Advanced Clinical Recruitment
+44 (0) 114 270 1741
LinkedIn Search: Sam Caley Quality Assurance
Keywords: QA, Quality Assurance, GCP, GxP, GMP, GLP, Good Clinical Practice, Auditor, Audit, GCP Audits, Clinical Quality Assurance, Lead Auditor, Head or Quality, Senior Auditor, Senior Manager, Management, Audit Strategy, Structure, Home Based, Field Based, Pharmaceutical, Jobs in Pharma, Pharmaceutics, Generics, Specials, CRO, CQA, GCP Auditor, Manager, GCP Manager, London, Remote, Flexible, Central
Regus 2nd Floor
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