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  • 21 Nov 2018

    Senior / QA Operations Specialist


    Permanent Position
    We are working with a Biopharmaceutical Manufacturer (European MNC) and they are looking for a Senior / QA Operations Specialist to join their organisation.

    Job Description

    • The Senior QA Operations (Ops) Specialist has responsibility to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements and Company Manual.
    • Representative of the Operational QA in project teams (e.g. Master Batch records, equipment, cleaning and process validation).
    • Participate in the general QA activities and assist in the different areas of the QA function (Compliance /Release/Change control)
    • Manage quality issues and investigations (e.g. deviations, trends, Out of Specification) with the respective departments
    • Perform review of GMP relevant documents for compliance with Standard Operating Procedures across several customer groups (e.g. TEDI documents, SOPs, documents etc.), including filing and archiving documents owned by QA
    Expires on 21 Dec 2018

    Posted By

    Axel Lee Kian Heng (Reg No: R1110163)

    Tel: +65 6738 6228


    • Masters or Degree in Natural Sciences (Biotech preferred) or related experience in sterile manufacturing
    • Minimum 2 to 8 years experience in pharmaceutical GMP-regulated industries (Biotech preferred), with a minimum of 5 years in Quality Assurance and/or Compliance
    • Strong experience with health authority inspections from major Health Authorities, e.g. USA, EMEA, Canada, Japan, Brazil etc.
    • Related experience should be in GMP-regulated industries in Quality systems and Documentation
    • Must have a working knowledge of FDA and ex-USA regulatory requirements as well as pharmaceutical industry quality systems

    Kindly indicate your current/last salary details and your notice period

    Interested candidates kindly forward your CV to (Axel Lee Kian Heng, Reg No: R1110163)
    Feel free to forward this great opportunity to someone who would be a great fit for this role.

    All information will be kept strictly confidential. We regret to inform that only successful applicants will be contacted.

    PeopleSearch Pte Ltd
    EA License No: 16S8057

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