QC Executive

JOB SUMMARY

We are looking for a QC Executive to support our Quality Control laboratory operations and ensure compliance with GMP, GLP, GDP, QMS and regulatory requirements. The role will oversee daily QC testing, support laboratory personnel, review analytical results and documentation, monitor stability activities, and support QMS activities including OOS, deviations, CAPA and Change Control, as well as audits and other quality-related activities.

The ideal candidate should have a strong foundation in laboratory practices, good attention to detail, and the ability to work effectively in a GMP-regulated manufacturing environment.

KEY RESPONSIBILITIES

1. Ensure QC activities comply with GMP, GLP, GDP and regulatory requirements.
2. Supervise and support QC personnel in daily laboratory testing and activities.
3. Review analytical results, laboratory documents and QC records before release.
4. Review and approve Raw Material and Packaging Material results in SAP for release and production use.
5. Conduct GMP walkabouts and maintain laboratory safety, cleanliness and housekeeping.
6. Monitor the stability programme and retention samples according to the approved schedule.
7. Ensure calibration, maintenance and proper use of laboratory instruments and equipment.
8. Assist in OOS/OOT, deviation, CAPA and Change Control investigations.
9. Review and update QC SOPs, specifications and test methods.
10. Support internal/external audits and regulatory inspections.
11. Assist in validation activities and preparation of QC documents for regulatory submissions.
12. Maintain inventory of chemicals, reference standards, reagents and other QC consumables.
13. Perform other duties assigned by the reporting manager.

REQUIREMENTS

1. Bachelor's degree in Chemistry, Pharmaceutical Science, Applied Science, or a related field.
2. Preferably 3-5 years of relevant QC experience in a GMP-regulated manufacturing environment.
3. Good knowledge of GMP, GLP, GDP and QMS requirements.
4. Experience in laboratory testing and analytical techniques such as HPLC, GC or other relevant instruments is an advantage.
5. Experience in conducting investigations related to OOS/OOT, deviations, CAPA, Change Control, stability and validation activities is preferred.
6. Hands-on experience with SAP, particularly reviewing and approving Raw Material and Packaging Material results, is an advantage.
7. Experience in supporting or participating in internal and external audits is an advantage.
8. Good documentation, analytical, problem-solving and communication skills.
9. Able to work independently and effectively within a team.
10. Strong attention to detail and commitment to quality and compliance.

KEY COMPETENCIES

1. Able to work independently with minimal supervision.
2. Able to multitask, prioritise and manage deadlines effectively.
3. Strong analytical and problem-solving skills.
4. Good attention to detail and commitment to quality.
5. Good communication and teamwork skills.
6. Able to supervise, coordinate and guide QC personnel.
7. Strong quality, compliance and QMS mindset.
8. Good time management and organisational skills.
9. Adaptable and able to work effectively in a fast-paced GMP environment.