- To provide oversight in ensuring site activities, projects, program and initiatives are executed and conforming to established specifications, procedures and in compliance of cGMP and J&J requirements.
- Responsible for all aspects of quality assurance activities of raw and packaging materials, in process and finished products.
- Responsible for completeness of documentation prior to release of FG under New Product Development (NPD), cost / quality compliance project with complete Authorization for Product Release (APR) / Global Change Control (GCC) and meeting quality requirement.
- To support in NPD/NPI processes to ensure consistency of execution and in compliance of GMP requirements.
- Ensure change management and risk management is properly executed for the site.
- To lead/support in all quality activities in shopfloor including sampling and in process inspection.
- To lead/support in the Quality Value Stream Mapping and the initiatives to drive process improvement and robustness which includes global and regional strategic initiatives.
- Responsible for overall batch record management compliance and product release and disposition on timely manner.
- To lead/support in the management of Investigation (INV)/Nonconformance (NC), complaints and CAPA and monitoring of the overall trending of INV/NC and complaints with action plans to drive improvement.
- To support in the management of audit for the site which covers internal audits (self-assessments), JJRC audits, Health Authority audits and other external audits such as supplier audits in accordance to standardized process.
- Ensure Validation activities such as Equipment & Facilities Qualification, Process Validation, Computer System Validation, etc. of the site are planned and carried out in accordance to J&J requirement.
- To lead and support in shopfloor training and classroom training for office based employees. Ensure OSI re-certification and GMP training carried out according to defined frequency.
- To work closely with Source Quality on the local supplier quality management in ensuring the confidence in a supplier’s ability to produce and deliver quality product that meet the company standards and requirements.
- To lead and support on the OGSM related projects and plant initiatives
- To support in MRA program and Shop Floor Quality Gemba in promoting proactive quality culture and ensuring the Quality and Compliance of shop floor as per company standards and requirements.
- Cultivates a culture of proactive quality at shop floor and all levels.
- To lead/support in the local change control management which include evaluation of change management for the site.
- To administer local system and global system such as Symphony and Tru system and support in the training and troubleshooting.
- Candidate must possess at least a Bachelor's Degree in Engineering or any related field.
- At least 3 Year(s) of working experience in the related field is required for this position.
- GMP experience in a QA role, in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production.
- Preferable to have experience in Quality Management System covering Validation, Handling of Nonconformances and CAPA, Root Cause Analysis, Good Hygiene Practices, Pest Control, Change Management, Risk Management and good understanding of Halal and cGMP requirements.
- Preferably Junior Executive specialized in Quality Control/Assurance or equivalent.
Johnson & Johnson Sdn. Bhd. (8275)