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Senior Quality Associate - Reg & Comp Job

Date: Oct 30, 2017

Location: Singapore, SG

Company: MSD

Requisition ID: REG003113

  • Implement
    audit programs to ensure all facilities in Singapore are manufactured in
    compliance with corporate and site policies and regulatory standards and GMPs
    guidelines. Lead and assist in conducting internal and supplier audit as per
    schedule. Plan and manage preparation work for corporate and regulatory audits
  • Lead
    and coordinate all GMP related activities and compliance issues.
  • Managed
    and coordinate Quality Risk management and integrate mitigation plan and
    technique based on product type and associated technology.
  • Provide
    regulatory support to ensure alignment of local operations with applicable
    regulatory filings, international and national requirements, site and corporate
    policies and procedure.
  • Promote site quality culture
  • Develop
    adequate understanding into regulatory guideline, company policies, procedure
    and standards.
  • To
    ensure site is in compliance to regulatory guideline, company policies and
    standards, conduct walk through audits, internal audits in all GMP relevant
    systems as per schedule. Present audit findings to all levels of management.
  • Applies knowledge of internal and external compliance
    requirements (e.g. EU GMP, US FDA) and quality guidelines to all aspects of
    product specifications, manufacturing processes, warehouse/ distributions
    systems and lab functions.
  • Coordinate
    Quality Risk Management on site, including site risk register administration
  • Prepare,
    co-ordinate, conduct walkthrough, internal and/or supplier audits. May function
    as a lead auditor which assumes the responsibility of coordinating the efforts
    of a team of auditors and leading the audit process.
  • Participate
    and coordinate regulatory agency inspections and corporate audits. Assist to
    follow up all action plans and ensure effective regulatory commitment tracking
    to assure no overdue CAPA.
  • Work
    closely with other functional groups to raise the level of awareness towards
    cGMP, company policies and procedure, regulatory guides and codes.
  • Co-ordinate
    and support regulatory submissions made by site.
  • Maintain
    Quality Compliance Department files, performance metrics and other general
    administrative tasks.
  • Manage
    site quality council meeting preparation and collate site quality metrics for reporting
    to site and corporate management.
  • 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.
  • Supervise
    and oversee Third Party Contractors, where applicable.
  • Perform
    any other tasks as assigned by manager
  • Able
    to interpret and apply Quality System to ensure adherence to quality standards/
    guidelines and achieve a state of control.
  • Frame
    the correct problem statement when conducting audit, partner with various
    functions providing guidance in root cause analysis and problem solving techniques.
  • Liaise with Regulatory Affairs for site regulatory
    submissions, ensuring data accuracy.
  • Manage
    and perform audits using thorough understanding of audit management
    methodology.
  • Able
    to develop audit reports with minimal oversight. Communicate audit plans,
    findings and overall audit outcomes to internal and external groups. Able to
    assess CAPA effectiveness, trends and potential quality impact to drug
    products.
  • Able to independently solve problems that arise within
    job responsibilities and expectation. Able to organize information in a logical
    way and combine data and information from multiple sources in new ways to
    determine causes of issues.



Qualifications

  • Bachelor 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
  • Auditing experience preferred
  • A
    continued improvement mindset.
  • Good
    knowledge and understanding of GMP and
    application of
    pharmaceutical regulatory requirements
    .
  • Good
    knowledge and application of Lean.
  • To be familiar with simple
    statistic to apply statistical analysis and process control techniques.
  • Experience in MS-office
    applications.
  • Proficient in English.
  • 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 is
    preferred for the roll out of corporate automation system.
  • Good knowledge of system
    lifecycle management.




Job: Regulatory Compliance
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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