Deskripsi Pekerjaan
Are you a seasoned Quality Assurance professional with a passion for ensuring regulatory excellence and product integrity? We are currently representing a prestigious global pharmaceutical firm in search of a Quality Assurance Manager to spearhead commercial QA operations during a significant divestment transition in the APAC region.
This contract position, based in the vibrant city of Petaling Jaya, Selangor, offers a competitive remuneration package of RM 12,000 – RM 15,000 per month. As the commercial QA lead, you will be at the forefront of maintaining regulatory compliance, safeguarding product quality, and ensuring uninterrupted supply chains throughout the transition period.
Key Responsibilities:
- Develop and implement quality strategies to support the divestment process across APAC markets.
- Ensure full compliance with local and international regulatory requirements (e.g., NPRA, FDA, EMA).
- Manage quality management systems (QMS) including document control, deviations, CAPA, and change control.
- Lead internal and external audits, including supplier and regulatory inspections.
- Collaborate with supply chain teams to mitigate risks and ensure product availability.
- Oversee quality agreements with partners and third-party manufacturers.
- Provide QA oversight for commercial products, including batch release and stability studies.
- Act as the primary QA contact for regulatory agencies during the divestment.
The ideal candidate will possess a strong background in pharmaceutical QA, with experience in managing complex transitions and cross-functional collaboration. This is an excellent opportunity to contribute to a high-impact project within a leading organization.
If you are ready to take on a challenging and rewarding role, we invite you to apply now and join our talent pool for this exciting contract assignment.
Tanggung Jawab
- Lead quality assurance activities for commercial products in APAC during the divestment transition.
- Ensure compliance with regulatory standards including GMP, GDP, and local drug regulations.
- Manage and maintain Quality Management Systems (QMS) to uphold product quality.
- Conduct internal and supplier audits, and coordinate with regulatory bodies for inspections.
- Oversee batch release, stability studies, and quality metrics.
- Collaborate with supply chain teams to ensure product continuity and mitigate disruptions.
- Develop and manage quality agreements with partners and contract manufacturers.
- Drive continuous improvement initiatives to enhance quality processes.
Kualifikasi
- Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
- Minimum 7 years of quality assurance experience in the pharmaceutical or biotech industry.
- Strong knowledge of GMP, GDP, ICH guidelines, and regulatory requirements in APAC.
- Experience leading or participating in regulatory inspections and audits.
- Proven ability to manage quality systems and lead cross-functional projects.
- Excellent problem-solving, analytical, and decision-making skills.
- Effective communication and stakeholder management abilities.
- Prior experience with divestments, mergers, or supply transitions is a distinct advantage.