Location: Wellington / Wairarapa, Upper Hutt
Position: Science & Technology, Biotechnology
Schering-Plough Animal Health, a leading multi-national pharmaceutical organisation, is seeking a Quality Assurance Systems Manager to join their Quality group, based at Upper Hutt, Wellington
The QA Systems Manager manages a team to provide assurance that the products meet with global quality policies, quality standards, current Good Manufacturing Practices and registration requirements with global quality policies, quality standards, current Good Manufacturing Practices and registration requirements.
Specific systems include regulatory affairs, documentation control, archive maintenance, GMP/GLP compliance, supplier quality audits (including 3rd party manufacturers), internal audit programme, contracts review, product stability programmes, site master file, master validation plans, change proposal, QA input into validation activities, deviation and out-of-specifications.
The QA System Manager will also manage in-process and final product release including preparation nd submission of market specific protocols of analysis for government agencies
The Person:
•Science based tertiary qualification.
•Formal Quality Training including statistical process control
•Preferably an understanding of vaccine or pharmaceutical manufacture
•In-depth understanding of GMP/GLP environments and associated QA systems
•Understanding of validation requirements in a GMP aseptic environment
•People management and leadership experience
•Training as a Trainer experience
•Quality Auditing experience
•Strong attention to detail
•Excellent analytical and problem solving skills
•Strong planning and organising ability
•Customer focussed