Main Duties and Responsibilities:
- Oversee routine QC activities, including raw material and packaging component testing, bulk testing, filling and packaging line inspection, and product release.
- Ensure QC functions are performed in adherence to GMP/GLP requirements such as employee training and qualification, deviation and OOS result investigation, quality trending, specification design and update.
- Establish KPIs for key QC units and positions. Implement continuous improvement plans based on the analysis of KPIs.
- Collaborate with relevant parties, internal and/or external, in the investigation of deviations and customer complaints. Design and implement effective CAPAs according the identified root cause.
- Provide supervision to QC units on line trials, first production batches, label claim determinations, stability and compatibility studies.
- Gauge product quality based on specification and historical performance. Review and approve range boards along with relevant departments.
- Ensure all QC tasks are completed in pre-determined cycle time, and notify all stakeholders if there is any delay.
- Review and approve QC SOPs, test methods, protocols, and other GMP documents as required.
- Perform other duties as assigned
- Bachelor’s Degree or equivalent
- 5 years related experience in a GMP regulated industry
- Thorough knowledge of GMPs/GLPs and regulatory requirements
- Proven organizational skills, communication skills, and computer literacy.
- Able to work independently or in a team as needed, with excellent interpersonal skills.
- Managerial skills: adaptable to change, multi-tasking, proactive to continuous improvement.