Senior Quality Associate - Release (Tableting) Job - Singapore
- Provide quality oversight for IPT related activities and quality system processes
- Ensure material supplied is fit for purpose for customer and/ or patient use
Product Annual Review
- Initiates and facilitates Product Annual Review activities.
- Tracks Product Annual Review recommendations and ensures action plan completion
- Compiles reports for approval, including: Cover/Approval Page, Executive Summary, and issue report.
- Batch-sheet, Cleaning related documents and SOP Documentation
- Reviews and approves new batch-sheet, ongoing mark-up, and changes.
- Reviews and closes batch-sheet and related documentation.
- Reviews change control (LCR, PCR) and validation protocols where required.
- Reviews and approves BOM and labels.
- Reviews and approves batch-sheet SOPs and procedures.
- Reviews and approves cleaning protocol, cleaning reports, and cleaning records.
- Supports developmental/commercialization activities.
- Participates in investigations, reviews and approves investigation reports.
- Tracks Corrective Actions/Preventive Actions and ensures completion.
- Generates atypical summary reports.
- Performs trend analysis of root causes and facilitates on a periodic basis.
- Reviews and closes completed OOS.
- Completes batch disposition for release form and updates in Data3 system.
- Communicates to Qualified Person on any information that may result in revoking of released status of any shipped material.
- Manages requests for specific COA requirement requests and summaries.
- Reviews and approves change control request, qualification activities from quality perspective.
- Acts as Quality representative in change control meetings.
- Ongoing monitoring of change control status.
- Collaborates with other functional department in each plant to develop action plans for identified audit issues, identify the non-compliance issues and proactively collaborate with the relevant department to resolve issue.
- Work closely with other functional groups to raise the level of awareness towards cGMP, company policies and procedure, regulatory guides and codes.
- Participate in continuous improvement initiative as part of the MPS culture in MSD Singapore.
- Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
- To independently solve problems that arise within job responsibilities and expectation; organize information in a logical ways and combine data and information from multiple sources in new ways to determine causes of issues by applying knowledge of technical and scientific knowledge, statistical data evaluation.
- Develop and oversee plans for all activities related to local/regional deviation management projects including connection to product recalls and clinical stock recoveries.
- Maintains appropriate quality oversight of SOPs for manufacturing and operational activities.
- Draft, gain approval and execute IQ, OQ, and PQ protocols for moderately complex systems. Identifies validation issues and supports development of remedial actions.
- Bachelor Degree in Science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience.
- 3 to 6 years of relevant experience in quality assurance in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA
- Have a basic understanding of Lean
- Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements.
- Audit experience preferred. Good knowledge of Singapore, US and European regulatory requirement
Job: Qual Assurance & Ops Generic Job Title:Spclst, Quality Assurance
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Pharmaceutical, Law, Environmental Health & Safety, Compliance, Science, Legal, Customer Service, Healthcare