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Senior Quality Associate - Release (Tableting) Job Singapore,  

Posted on : 22 April 2017

Project Description

Senior Quality Associate - Release (Tableting)-QUA005755Description- Provide quality oversight for IPT related activities and quality system processes- Ensure material supplied is fit for purpose for customer and/ or patient useProduct 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.Deviation/Atypical/OOS/Customer Complaints- 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.Product Release- 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.Change Control- 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.Qualifications- 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 requirementJob: Qual Assurance & Ops Generic Job Title:Spclst, Quality AssurancePrimary Location: APAC-SG-Singapore-SingaporeEmployee Status: RegularTravel: NoNumber of Openings: 1Company Trade Name:MSD Job Segment: Pharmaceutical, Law, Environmental Health & Safety, Compliance, Science, Legal, Customer Service, Healthcare


Singapore, SG

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