External Quality Specialist (Pharma/ 3 Yr Contract)

Job Purpose

• Serve as functional quality representative of external manufacturing in Asia Pacific region, including South Korea. Candidate will be required to liaise with colleagues and third party manufacturers in the APAC region, including South Korea.
• 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.

Responsibilities

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. Liaise with Korean-speaking counterparts to 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

Others

• Any Ad Hoc activities as specified by the Reporting Manager

REQUIREMENTS

• More than 5 years' working experience in quality or manufacturing in pharmaceutical industry
• In depth knowledge of GMP (ASEAN, EU, ICH PIC/S)
• Proficiency (written and spoken) in Korean (TOPIK I Level 2 or equivalent) to liaise with South Korean counterparts
• 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 .

We regret only shortlisted candidates would be contacted.

Sherry, Yew Koon Ng EA License No.: 02C3423 Personnel Registration No.: R1657259