
Operational Quality Manager
- Kuala Lumpur
- Tetap
- Sepenuh masa
- Authorized Person (AP) for CHQSC Kuala Lumpur and perform all task relevant to batch release process including approval of batch in MERPs, preparation of CoA, retain sample review for products manufactured or packed in CHQSC KL in accordance with regulatory and GMP requirements
- Coordinating Product Incident Management (PIRC/ Recall), Product Complaint, Periodic Product Review at site, monitor and report KPI related to OQ section in weekly and monthly basis.
- Leading in deviation management improvement as site deviation management champion and facilitate in on-line problem solving and conduct investigations together with cross functional departments as required and authorized to provide batch disposition for release upon reviewing deviation reports.
- Revise SOPs related to OQ section in accordance with Haleon Quality System (HQS) and Regulatory requirement.
- To assist site and involve in preparation of audit, external/ regulatory audit.
- To conduct site internal audit as required.
- Leading OQ oversight team to ensure shift-based oversight of facilities, equipment, and personnel to ensure compliance to procedures in real-time.
- Conduct training in GMP and Quality / GMP related SOPs.
- Other duties as assigned by the Site Quality Head from time-to-time eg: department OPEX & CAPEX
- Overseeing validation and qualifications
- Bachelor’s Degree in Pharmacy, Science, or an engineering discipline, OR equivalent level of knowledge, understanding and hand on experience of Good Manufacturing Practices in the pharmaceutical environment.
- Minimum 6 years of Manufacturing/Quality experience in the Pharmaceutical industry.
- Experience with the application of Quality Management Systems in manufacturing, warehousing and distribution.
- Ability to work independently and prioritize workload.
- Excellent oral and written communication skills.
- Strong interpersonal skills with an ability to enable and drive change.
- Problem identification and solving skills.
- Experience of working with multi-functional teams.
- Technical knowledge and competency in manufacturing and packaging processes
- Thorough knowledge of GMP and GLP.
- Skilled at auditing and report writing.