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