Quality Control Specialist (Pharma / MNC | Full-Time, Office Hours) #HJG
Key Responsibilities
- Investigate and resolve laboratory incidents, ensuring proper documentation and corrective actions.
- Review and approve laboratory investigation reports, including out-of-specification (OOS) reports.
- Evaluate the adequacy of corrective and preventative actions and assess their impact on materials.
- Review and approve analytical procedures for compliance with company policies, ICH guidelines, and regional regulatory requirements.
- Assist in the preparation of quality agreements and perform periodic supplier evaluations to ensure regulatory and company compliance.
- Conduct incoming quality control inspections of raw materials to verify conformance with specifications.
- Coordinate sampling of raw materials with production planners and testing laboratories, ensuring timely testing and retesting.
- Track the status of raw materials from receipt to final disposition, including SAP management of retest and expiration dates.
- Sample and monitor the purified water system used in laboratory operations; review trend reports and identify potential root causes of out-of-specification or out-of-trend results.
- Manage clinical supply operations logbook system and perform quality reviews to ensure adherence to company procedures and cGMP standards.
Requirements
- Good knowledge of cGMP pharmaceutical manufacturing and inspection requirements of pharmaceutical products.
- Interpreting multiple standards and applying them to department activities.
- Detail oriented with proven organizational skills.
- Handling a wide variety of tasks under time constraints.
- Interpreting and evaluating data and summarizing results.
- Good interpersonal skills with team player orientation.
- Minimum Degree in Science or equivalent with at least 2 years of relevant experience in the pharmaceutical / chemical industry.
- Experience in operating laboratory equipment such as HPLC, GC, KF Titrators.
- Working knowledge of cGMP and regulatory requirements related to Quality is an advantage.
- 5 days office hours
If you are interested in the position, do kindly drop your most updated resume to
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599