Senior QA Specialist, Biopharmaceuticals (1 year contract)

  • Location

    Singapore

  • Sector:

    Life Sciences

  • Job type:

    Contract

  • Salary:

    S$7000 - S$8000 per annum + 1 month completion bonus

  • Contact:

    Abhik Damani

  • Contact email:

    abhik.damani@voltasia.com.sg

  • Job ref:

    BBBH9445_1624498752

  • Published:

    about 1 month ago

  • Expiry date:

    2021-07-24

  • Consultant:

    #

My client is a global leader in the biotechnology industry and now seeks an experienced QA Specialist to help with a transformation project. This will be a fixed 1 year contract with excellent opportunities for internal mobility.

Responsibilities:

  • Provide QA oversight and ensure that medicinal products are manufactured in accordance with global Quality Systems and local site requirements
  • Provide QA oversight of investigations and Corrective Action and Preventive Action Management System
  • Ensure investigation are appropriately conducted considering robust analysis, documentation of root causes and identifying potential risk to operations and product quality
  • Assume responsibility for managing of Commercial Products disposition activities in accordance with procedures, performance measures, and standard lead times.
  • Lead in the design and implementation of department and cross-functional initiatives
  • Perform routine and non-routine activities, with adequate QA oversight to ensure that appropriate standard operating procedures (SOPs) and compliance standards are adhered to, as follows:
  • Support document review and approval in Electronic Document Management System (EDMS)
  • Serve as a technical subject matter expert support of departmental functions and during audits
  • Interface with appropriate departments to ensure that lot disposition items are complete and timely notification to Management of all known delays and significant Quality issues is provided
  • Manage and support lot disposition activities and resources to ensure adherence to schedule

Requirements:

  • Degree in Life Sciences or Engineering discipline or equivalent
  • At least 5 years of working experience in QA from a pharmaceutical/biotech plant environment
  • Good knowledge of quality systems and QA principles, practices and standards for the pharmaceutical industry
  • Ability to interpret and relate Quality standards for implementation and review
  • Good interpersonal, oral and written communication skills
  • Ability to prioritize, plan and manages deliverables effectively
  • Proven ability to work well under pressure



Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).