Quality Assurance Executive
Company Description
Pharmaniaga LifeScience Sdn Bhd (PLS) is the only specialized sterile small volume injectable (SVI) plant in Malaysia. The facility was awarded the European Union (EU) Good Manufacturing Practice (GMP) certificate in 2013. The plant is equipped with high-tech laboratories and is the first Malaysian pharmaceutical plant to receive the EU GMP certification. It is located in Puchong, Malaysia.
Role Description
•Review and manage GMP-related documents (Deviation, CAPA, Investigations, Master Records, Validation, etc.) and maintain relevant registers.
•Conduct scheduled PQRs, collect and analyze data, and provide improvement recommendations.
•Conduct audits (GMP, GDP, ISO standards), report findings, and follow up on corrective actions.
•Manage complaint investigations, communicate with complainants, and maintain complaint records and registers.
•Create batch numbers, maintain production structures, and ensure BOM availability in ERP.
•Final review of batches and documentation before release, including decision-making in the absence of Head of QA.
•Coordinate recalls, document processes, notify authorities, and ensure recalled products are returned.
Issue rejection forms/labels and ensure proper documentation and labeling of rejected items
Qualifications
•Bachelor in Science or Pharmacy or Microbiology or Chemistry or related field.
·Minimum 2 years’ experience in related field.
·Proven Supervisory and Technical Skills.
·Knowledge and understanding of pharmaceutical laboratory and statutory quality regulations & legislation.
Company Description
Pharmaniaga LifeScience Sdn Bhd (PLS) is the only specialized sterile small volume injectable (SVI) plant in Malaysia. The facility was awarded the European Union (EU) Good Manufacturing Practice (GMP) certificate in 2013. The plant is equipped with high-tech laboratories and is the first Malaysian pharmaceutical plant to receive the EU GMP certification. It is located in Puchong, Malaysia.
Role Description
•Review and manage GMP-related documents (Deviation, CAPA, Investigations, Master Records, Validation, etc.) and maintain relevant registers.
•Conduct scheduled PQRs, collect and analyze data, and provide improvement recommendations.
•Conduct audits (GMP, GDP, ISO standards), report findings, and follow up on corrective actions.
•Manage complaint investigations, communicate with complainants, and maintain complaint records and registers.
•Create batch numbers, maintain production structures, and ensure BOM availability in ERP.
•Final review of batches and documentation before release, including decision-making in the absence of Head of QA.
•Coordinate recalls, document processes, notify authorities, and ensure recalled products are returned.
Issue rejection forms/labels and ensure proper documentation and labeling of rejected items
Qualifications
•Bachelor in Science or Pharmacy or Microbiology or Chemistry or related field.
·Minimum 2 years’ experience in related field.
·Proven Supervisory and Technical Skills.
·Knowledge and understanding of pharmaceutical laboratory and statutory quality regulations & legislation.