Quality Specialist (Quality Management System/ ASEAN)
Industry : Pharmaceutical
Salary up to $10,000 depending on experience
- Manage third party manufacturers located in China and ensure that manufacturing operations are conducted, and products are manufactured in accordance with GMP, the marketing authorisation and the quality agreement.
- Support on the QMS and all projects related to New product launches in performing Due Diligence.
Quality Management of third party manufacturers
- Perform GMP audits of third party manufacturers and CAPA (Corrective action and preventive action) follow-up.
- Complaints management. Review complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trend.
- Management and support product recall and return.
- Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend.
- Deviation management and out-of-specification investigation. Review major / critical deviations, OOS investigations, CAPA plan and effectiveness review. Monitoring of deviations / OOS / CAPAs trends.
- Participate in the evaluation, selection and approval of third party manufacturers
- Management of Quality Agreement with third party manufacturers. Setup / review / update of quality agreement.
- Management of Product Quality Reviews (PQR). Review of PQR, corrections/follow up action. Monitoring of PQRs trend.
- Review of technical reports e.g. stability reports, process /analytical validation reports etc.
- Quality Risk management in case of major / critical quality issue. Coordinate and participate quality risk meetings and prepare rapid quality notifications.
- Management of Quality and Safety Material Product (QSMP). Setup / coordinate / review / update of QSMP.
- Management of Quality Monitoring and Quality Review. Coordinate and participate in quality monitoring and quality review of third party manufacturers.
- Perform risk ranking of third party manufacturers.
- Manage termination of activity with third party manufacturers.
Quality Operations of EM CHC China Entity
- Support/perform management and continuous improvement of Quality Management System (QMS).
- Support/perform implementation of global quality standards and procedures.
- Support Quality Documentation System management, documentation Retention, Archival and Destruction.
- Support/perform Qualifications and Training of Quality/Regulatory personnel.
- Support/perform Self Inspection.
Quality Support for Transversal Projects
- Provide Quality support for transversal project e.g. new product launch, site transfer or repatriation.
Requirements & Qualifications
- Degree in Pharmacy / Pharmaceutical Science / Related Science
- At least 5 years working experience in quality or manufacturing in pharmaceutical industry.
- In depth knowledge of pharmaceutical/nutraceutical/cosmetics/medical devices GMP and regulations (ASEAN, EU, ICH, PIC/S, local market GMP regulations).
- Computer skills: Word, Excel, Phenix (Quality tool), GEODE+ (GMP Documentation system).
If you possess above relevant skillsets, please send in your updated CV in word format to Apple.email@example.com
Lim Pey Chyi
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579