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Abbott - Head - TPM Quality Assurance - Biosimilars
Abbott - Head - TPM Quality Assurance - BiosimilarsAbbott Healthcare Pvt. Ltd. • Mumbai, India
Abbott - Head - TPM Quality Assurance - Biosimilars

Abbott - Head - TPM Quality Assurance - Biosimilars

Abbott Healthcare Pvt. Ltd. • Mumbai, India
9 days ago
Job description

Job Function : TPMs supplying to Biosimilars in India and APAC region

  • Quality Oversight of TPMs
  • QMS Management at TPMs
  • Inspection readiness for Abbott audits and Regulatory audits for sites under responsibility
  • Investigations of Products failures, OOS, Complaints pertaining to Abbott products
  • Review of APQRs
  • GMP compliance at TPMs.
  • Compliance to Abbott procedures and policies.

Core Job Responsibilities :

  • Responsible and accountable for the oversight of quality operations and GMP compliance across the TPMs under responsibility of EPD Biosimilars Operations in India.
  • Effectively monitoring the rating of responsible TPM sites.
  • Leading the implementation of quality strategy and plan at the TPM sites including implementation of Abbott policies.
  • Implement quality Projects at identified TPMs from time to time
  • Ensure Quality and compliance to regulatory wrt labelling, stability studies and documentation to deliver acceptable quality products coming TPM sites to consumers on sustainable basis.
  • Develop strategy on quality as per Abbotts EPD requirements for the supply chain organization in the third party sites in applicable region.
  • Promote QMS as important management tool with increased visibility across the business and guide the team for effective implementation at 3rd party contractors.
  • Create culture which imbibes quality as a way of working through identified trainings and awareness programs for assigned TPM sites.
  • Establish and implement a process to ensure all customer complaints / queries are addressed as per Abbott policy in stipulated time at applicable TPM sites.
  • Periodic quality reviews with responsible TPM QA team.
  • Supervisory / Management Direct Reports : 00

  • Indirect Reports : 00
  • Position To identify training needs and support the TPM for Biosimilars portfolio

  • Monitor and ensure complaints are closed within timelines with adequate investigations.
  • Complete QA review and approval for FLQR on time , change control, exception documents for QA standpoint
  • Ensure supply and commitment to regulatory filings in Abbott markets.
  • Ensure change controls are assessed in a complaint manner and the products are supplied to respective markets only when changes are approved.
  • Minimum M Pharm, M.Sc Biochemistry, Microbiology or equivalent

    Minimum Experience / Training Required :

  • Total experience (in years) : Minimum 12 years
  • Experience in Quality function of a Biosimilar site is a positive
  • (ref : iimjobs.com)

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    Quality Assurance • Mumbai, India

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