PV & QA Associate

Steward Cross Pte Ltd; Singapore; On-site; SGD 28,000 - 37,000; Full time

Job summary

Steward Cross Pte Ltd in Singapore seeks a PV & QA Associate to support Packaging Materials, QA, and Pharmacovigilance activities. You will assist with material management, regulatory compliance, batch releases, and audits.

You should have a diploma in science and be ready to contribute to GVP and GxP processes, supporting the PV manager and QA team in daily operations and documentation.

Qualifications

• Diploma in Science or related field.
• Experience in pharmaceutical packaging and QA is a plus.
• Knowledge of GVP and GxP is preferred.

Responsibilities

• Manage packaging/ labeling materials and budgeting.
• Coordinate vendor audits and ensure print quality.
• Support regulatory compliance and market access.
• Perform batch records reviews and releases.
• Assist PV activities including literature searches.
• Assist audits and QA process improvements.

Education

Diploma in Science or related field

Job description

Job Title: PV & QA Associate

Department Name: Pharmaceutical Services

Reports to: Assistant Manager (PV/ QA)

Packaging Materials (PM)

• 1. 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,
• 2. Coordinate and manage (inclusive of auditing) the vendors of the packaging/ labelling materials to ensure the quality of print of packaging materials.
• 3. Regulatory administrative support in the management of packaging materials to ensure regulatory compliance and facilitate market access.

Quality Assurance (QA)

• 1. 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.
• 2. 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.
• 3. 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)

• 1. Perform literature searches in compliance with Good Pharmacovigilance Practice (GVP).
• 2. 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)