QA Manager - Beerse, Belgium
Job Title: Quality Assurance Manager
Location: Beerse, Belgium
Rate: To be Discussed
An innovative pharmaceutical company specialising in the research & development of numerous human medical disorders, are actively searching for an experienced Senior QA Manager to lead their Quality Operations team in Beerse, Belgium on a permanent basis.
• Through collaboration with Production, Maintenance, Qual/Val, QC and Quality System personnel, lead the QA Operations team as an expert resource in assessing and maintaining quality and compliance levels
• Continuously challenge the status quo and lead the development and implementation of breakthrough initiatives that deliver sustainable improvement in organizational and quality performance
• Ensure development, improvement and management of a robust and efficient quality release process, complying with internal and external regulatory requirements and supporting the business needs
• Continuity of supply: interact daily with Planning, Manufacturing, Packaging, QC and Supply Chain groups to assure that adequate resources are - report on resources issues and operating constraints
• Manage the writing and/or QA approval of GMP documents (work instructions, SOPs, …) to ensure QA oversight of the operational activities
• Ensure that deviations (incl. complaints) with possible impact on quality, compliance and registration, are evaluated (incl. escalated where required), and that adequate corrective and preventive actions are implemented to continuously improve the quality system
• Ensure that internal audits are executed and reported according to internal audit schedule
• University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering)
• 10 years' experience in pharmaceutical industry (ideally with a mix of production, QA/QC expertise)
• In depth understanding of pharmaceutical production (manufacturing and packaging) and the specific technologies that are being applied, qualification, validation, testing, release and distribution processes
• Thorough knowledge of pharmaceutical legislation, in cGMP regulations (domestic & international), ICH guidelines, policies, standards and procedures
• Have been exposed to Health Authority inspections such as EMA and FDA
• Understands the business implications regarding quality positions and decisions
• Experience in sterile manufacturing environment is an asset
If you are interested in this opportunity, please send your CV to firstname.lastname@example.org
Alternatively, call 01625537555 (extension - 1024)
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