Quality Associate / Senior Associate (Release) Job

Date: Oct 1, 2018

Location: Singapore, SG

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Requisition ID: REL000338

  • Provide quality oversight for IPT related activities and quality system processes
  • Ensure material supplied is fit for purpose for customer and/ or patient use

QUALITY ASSOCIATE (RELEASE)

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.
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.
  • Perform any other tasks as assigned by manager.

SENIOR QUALITY ASSOCIATE (RELEASE)
  • In addition to the responsibilities of QUALITY ASSOCIATE (RELEASE):
  • 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.
  • 1 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: Release Control
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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