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