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Germany
QA Manager
Reference: | JCAO1508 | Location: |
Canada |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | €100000+ |
QA MANAGER
Our client a Canadian based early stage pharma company are currently seeking a QA Manager to join their team. Role is with an innovative company who are currently scaling up manufacturing and looking for a strong Quality professional to join them on the journey. Relocation and visa assistance will be provided
Role/Responsibilities:
• Ensure facility is compliant to GMP expectations for manufacture, storage,
distribution, and testing of drug product.
• Perform comprehensive oversight related to manufacturing/ packaging
complaints, deviations, change controls and analytical investigations to ensure
compliance with cGMPs, GLPs and SOPs.
• Work collaboratively with site operations in the resolution of cGMP deviations.
• Generation and approval of SOPs compliant with cGMP.
• Review and approval of validation protocols and reports, stability,
documentation, specifications, certificates of analysis, CAPAs, and
manufacturing batch records.
• Liaise with Operations and Regulatory Affairs, Manufacturers, Suppliers,
Customers, to obtain necessary information/documentation required for product
review/release/investigations.
• Maintain in-house training program for staff.
• Conduct internal self-audit and contractor cGMP audits, and host regulatory
inspections.
• Execute and enforce Quality Agreements with suppliers and contract
organizations.
• Perform other duties as assigned.
Skills/Experience
• Minimum BSc life sciences or in pharmaceutical sciences.
• Minimum 8 years QA experience in pharmaceutical GMP environment.
• Pharma and /or Biotech experience.
• Experience in conducting onsite and external audits to ensure compliance to
GMPs.
• Thorough understanding of Canadian GMP and ICH requirements for the
manufacturing and release of drug products.
For further information please contact James Cassidy or call in confidence +353 86 0204322
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