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[BioTechies] Quality Assurance Executive

  • BioTechies
  • Melaka

Bio Tree Pharmaceutical (Int'l) Sdn Bhd

We are looking for a Quality Assurance (QA) Executive to support and maintain GMP and quality systems in our manufacturing facility. This role is ideal for candidates who are detail-oriented, compliance-driven, and passionate about product quality and regulatory standards.

Job Summary:

The QA Executive supports the implementation and maintenance of the Quality Management System to ensure all manufacturing, testing, and documentation activities comply with GMP, PIC/S, and regulatory requirements. The role focuses on documentation control, in-process quality oversight, deviation handling, and continuous improvement to ensure product quality, safety, and compliance.

Key Responsibilities:

  • Coordinate and execute process validation activities, including protocol preparation, execution, and reporting.
  • Conduct or monitor equipment qualification and verification (IQ, OQ, PQ) to ensure validated state is maintained and prepare the required reports.
  • Manage supplier qualification and audits, ensuring only approved vendors and materials are used.
  • Collaborate with Production, QC, and Engineering to ensure compliance during validation and qualification activities.
  • Maintain validation master plan, schedules, and records as per GMP requirements.
  • Review and control SOPs, batch records (BMR/BPR), and quality documents.
  • Ensure timely requalification of equipment, facilities, and systems.
  • Ensure compliance with GMP, PIC/S, and quality system requirements across manufacturing and laboratory operations.
  • Handle deviations, CAPA, OOS/OOT, and quality events.
  • Conduct GMP floor inspections and support internal and external audits.
  • Assist in validation and qualification activities (IQ/OQ/PQ, process and cleaning validation).
  • Support GMP training and promote quality awareness.
  • Any other tasks assigned by QA Manager or upper management from time to time.

Job Requirements:

  • Diploma or Degree in Pharmaceutical Science, Biotechnology, Microbiology, Chemistry, or related field.
  • 1–3 years QA experience in pharmaceutical or biotechnology manufacturing (fresh graduates are encouraged to apply for junior roles).
  • Knowledge of GMP, PIC/S, and regulatory requirements.
  • Strong documentation, communication, and problem-solving skills.
  • Able to work independently and as part of a team.

Why Join Us?

  • Be part of a company shaping the future of functional health and wellness products.
  • Work in a collaborative and innovative environment with cross-functional exposure.
  • Opportunities for career development and industry-relevant training.

To apply for this job email your details to biokerjaya@bioeconomycorporation.my


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