Quality Assurance L2-2
Manage third-party manufacturers located in this region. Products are for local market and export markets. Perform regular monitoring and assessment of contracted GMPs activities.
Serve as functional quality representative of external manufacturing ATME for CMOs in work scope. Ensure that manufacturing operations are conducted, and products are manufactured in accordance with GMP, the marketing authorisation 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 Quality tasks assigned by the direct or dotted Manager.
Candidate may be required to adjust work schedule as needed based on the time zone of stakeholder, have good communication skills to liaise with stakeholders across different time zones and be able to work collaboratively with a remote team.
Experience & knowledge:
- At least 8 years working experience in quality or manufacturing in pharmaceutical industry.
- Ability to work in a matrix organization.
- Good team spirit and familiar with project development through cross-functional activities.
- Strong organizational and negotiation skills.
- Strong interpersonal and communication skills (writing & verbal) with excellent command of English.
- Pro-active with good sense of responsibility.
- Balanced Judgment / Risk based approach.
- Analytical thinking, hands-on troubleshooting style.
- Able to work independently and write technical reports.
- 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 / CONNECT (Quality tool and GMP Documentation system).
MAJOR DUTIES & RESPONSIBILITIES
(what the job does)
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 ATME 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.
- Prepare and participate in EM CHC ATME Quality Review.
- Support/prepare Monthly Quality Reports for reporting to Global Quality.
- Collect and consolidate the quality KPI’s (Key Performance Indicators) of third-party manufacturers 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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.