Fantastic opportunity has just opened for an experienced QA manager with strong background in management of suppliers and external operations.
The role is offered on 12 months contract with possibility to extend
• Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time.
• Monitor trends, identify issues, recommend and implement appropriate actions.
• Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.
• Coordinate and provide concurrences on deviations, change controls and CAPAs.
• Participate and Lead audits of External Manufacturers.
• Assists with regulatory inspections and provides follow up on regulatory commitments.
• Develop, implement, and review of SOPs for interactions with External Manufacturers.
• Investigate customer product quality complaints.
• Apply cGMP regulations and other international requirements to all aspects of the position.
• Coordinate change control documentation and approval process.
• Provide Quality oversight and participate on technology transfer teams.
• Interface with other functions (Operations, Planning, Technical Operations, etc) in the support of External Supply
• Providing support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and international manufacturing.
• Remaining current with HA and local regulations, guidelines, and quality practices associated with the pharmaceutical
University degree in scientific discipline
Strong prior experience in the manufacturing of Pharmaceuticals products and in QA function
Solid GMP guidelines experience
Trackwise quality systems experience
Prior experience in auditing and management of external suppliers
Michael Bailey International is acting as an Employment Business in relation to this vacancy.