PV & QA Associate

Job Title: PV & QA Associate

Department Name: Pharmaceutical Services

Reports to: Assistant Manager (PV/ QA)

Packaging Materials (PM)

• Responsible for the overall management of packaging/ labelling materials used in repackaging activities e.g., artwork management, material procurement, analysing material requirements, documentation, and budgeting,

• Coordinate and manage (inclusive of auditing) the vendors of the packaging/ labelling materials to ensure the quality of print of packaging materials.

• Regulatory administrative support in the management of packaging materials to ensure regulatory compliance and facilitate market access.

Quality Assurance (QA)

• Perform routine batch record reviews and releases of pharmaceutical products in addition to other quality releases in compliance to specifications or Company’s and/ or Principals’ (as applicable) requirements.

• Perform duties as assigned by the Quality Manager in relation to the maintenance and continuous improvement of Company’s Quality Management System (QMS) and compliance towards Good Distribution Practice and Good Manufacturing Practices standard in accordance to local Health Authorities and/ or Principal’s requirements.

• Support the Quality Manager in internal and external audit(s)

a) Support the planning, implementation, and follow-up of audits.

b) Support the handling of external Quality-related audits from Principals or Health Authorities.

Pharmacovigilance (PV)

• Perform literature searches in compliance with Good Pharmacovigilance Practice (GVP).

• Support the PV Manager in safety related issues towards compliance and continuous improvement of GVP.

Budget: $2,500 - $3,350 (monthly salary)Education: Minimum Diploma Level (Science)