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 Skills : quality manager QA Manager Senior Quality
QA Manager
QA MANAGER Our client a Canadian based early stage pharma company are currently seeking a QA Manager to join their team. For further information please contact James Cassidy or call in confidence Skills: quality manager QA Manager Senior Quality. Minimum 8 years QA experience in pharmaceutical GMP e...
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