MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Job Purpose: 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.
Deviation/OOS/Customer Complaints
Participates in investigations, reviews and approves investigation reports.
Tracks Corrective Actions/Preventive Actions and ensures timely completion.
Generates deviation summary reports.
Performs trend analysis of root causes on a periodic basis.
Reviews and closes completed OOS.
Product Release
Performs batch disposition and updates in Data3/SAP & GUMS 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 closes batch-sheet and related documentation.
Change Control
Reviews and approves change control request, qualification activities from quality perspective.
Acts as Quality representative in change control meetings.
Reviews change control (ACC, ECC, PCR).
Others 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.
Approve IQ, OQ, and PO protocols for moderately complex systems. Identifies validation issues and supports development of remedial actions.
Actively participates in the projects till its completion.
Qualifications Requirements: Bachelor’s Degree in science/ Life Science, Pharmacy, Pharmaceutical Science or Engineering or proven relevant experience
4 - 6 years of relevant experience in quality assurance in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA
Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements
Audit experience preferred. Good knowledge of Singapore, US and European regulatory requirements
Demonstrates active skill in challenging the status quo, offering practical alternatives.
Possess ability to actively seek opportunities for improving department processes and increasing efficiency.
Demonstrates capability in the application of appropriate troubleshooting, root cause analysis and problem solving techniques.
Project management skill
Good knowledge of system lifecycle management.
