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 manage packaging/ labeling materials, coordinate vendor audits, and provide regulatory support to enable market access.

You will perform QA batch reviews, assist in maintaining the QMS for GMP/GDP compliance, and support PV activities including literature searches to uphold safety standards.

Qualifications

• Minimum Diploma Level (Science).
• Familiar with Good Distribution Practice and Good Manufacturing Practices.
• Experience in pharmacovigilance (PV) activities is a plus.
• Ability to support internal and external audits.

Responsibilities

• Oversee packaging/ labeling materials management, including artwork, procurement, budgeting, and material requirements.
• Coordinate packaging vendors and audits to ensure print quality.
• Provide regulatory admin support for packaging materials to ensure compliance and market access.
• Perform batch record reviews and releases of pharmaceutical products per specs.
• Assist QA Manager with maintenance and improvement of the QMS and compliance with regulatory standards.
• Support audits planning, execution, and follow-up; handle external audits from principals or authorities.
• Conduct literature searches in line with GVP guidelines.

Skills

PV knowledge

QA familiarity

Documentation

Audit coordination

Education

Diploma in Science

Job description

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