- Serve as functional quality representative of external manufacturing SEA.
- Ensure that manufacturing operations are conducted and products are manufactured in accordance with GMP, the marketing authorization and the quality agreement.
- Contribute to business operation by establishing partnership with third quality manufacturers and providing quality oversight and support for quality operations activities.
- Any ad hoc tasks assigned by reporting manager
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 Asia Pacific Entity
- Management and continuous improvement of Quality Management System (QMS)
- Implementation of global quality directives, standards and procedures.
- Management of Quality Documentation System, Documentation Retention, Archival and Destruction
- Management of Qualifications and Training of Quality/Regulatory personnel.
- Management of Self Inspection
- Prepare and participate in EM Asia Pacific Quality Review
- Prepare Monthly Quality Reports for reporting to Global Quality
- Collect and consolidate the quality KPI's (Key Performance Indicators) from corporate entities managing third party manufacturers in the region for reporting to Global Quality
Quality Support for Transversal Projects
- Provide Quality support for transversal project e.g. new product launch, site transfer or repatriation
- Any Ad Hoc activities as specified by the Reporting Manager
- More than 3 years' working experience in quality or manufacturing in pharmaceutical industry
- In depth knowledge of GMP (ASEAN, EU, ICH PIC/S)
- Technical knowledge for various non-sterile dosage forms and APIs
- Knowledge of CMC regulatory affairs
- Experience in GMP audits
- Ability to work in a matrix organization
- Familiar with project development through cross-functional activities
- Strong organizational and negotiation skills
- Strong interpersonal and communication skills (writing & verbal) required to liaise with the professional team (Supply Chain, Procurement, Regulatory Affairs etc)
- Possess initiative
- Able to work independently and in a team environment.
- Ability to provide Balanced Judgment / Risk based approach
- Possess analytical mindset.
- Able to provide hands-on troubleshooting when required
- Able to work independently and write technical reports
- Computer literacy - Proficient in using Word, Excel, Share (Registration database); Phenex (Quality tool) and Domasys (Regulatory tool for Dossier management) systems.
- Preferably a Degree in Pharmacy / Pharmaceutical Science / Related Science
If you have the relevant skillsets, please send in your updated CV in word format to firstname.lastname@example.org.
We regret only shortlisted candidates would be contacted.
Ng Yew Koon Sherry
Senior Recruitment Consultant (R1657259)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Sherry, Yew Koon Ng EA License No.: 02C3423 Personnel Registration No.: R1657259