Talent.com
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
17 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)

    Create a job alert for this search

    Quality Assurance • Mumbai, India

    Related jobs
    Head of Quality Assurance(TPM- Biosimilars)

    Head of Quality Assurance(TPM- Biosimilars)

    Confidential • Mumbai, India
    Primary Job Function : TPM's supplying to Biosimilars in India and APAC region.Inspection readiness for Abbott audits and Regulatory audits for sites under responsibility. Investigations of Products ...Show more
    Last updated: 26 days ago • Promoted
    Head – TPMQA India - Biosimilars

    Head – TPMQA India - Biosimilars

    Confidential • Mumbai, India
    Primary Job Function : TPM's supplying to Biosimilars in India and APAC region.Inspection readiness for Abbott audits and Regulatory audits for sites under responsibility. Investigations of Products ...Show more
    Last updated: 28 days ago • Promoted
    Head of Quality Control

    Head of Quality Control

    D.P. Jewellers • Mumbai, Maharashtra, India
    Indian gems and jewellery industry, known for its exquisite craftsmanship, legacy of trust, and commitment to delivering timeless designs. With a strong presence in Central India, we are expanding o...Show more
    Last updated: 23 days ago • Promoted
    Head - HoReCa / MT

    Head - HoReCa / MT

    Backbay Beverages • Mumbai, Maharashtra, India
    Backbay is a wellness-focused beverage brand that aims to redefine premium hydration for modern India through sustainable practices. Co-founded by Bhumi Pednekar, an acclaimed actor and sustainabili...Show more
    Last updated: 30+ days ago • Promoted
    Clinical Quality Assurance Compliance & Training

    Clinical Quality Assurance Compliance & Training

    Maxis Clinical Sciences • Mumbai, Maharashtra, India
    Clinical Quality Assurance Compliance & training.Senior] Manager / Senior Manager.This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective.This rol...Show more
    Last updated: 30+ days ago • Promoted
    Quality Assurance Engineer

    Quality Assurance Engineer

    GoQuant • Mumbai, IN
    Job Description : QA Engineer (Paid).GoQuant is a financial technology company dedicated to providing high-performance trading solutions for digital assets. We empower professional traders and instit...Show more
    Last updated: 30+ days ago • Promoted
    Quality Assurance Manager

    Quality Assurance Manager

    Cirkla Inc. • Mumbai, Maharashtra, India
    We are seeking a results-oriented and experienced Quality Assurance Manager to lead the development and implementation of Cirkla’s Quality Management System. You will ensure that all processes, prod...Show more
    Last updated: 30+ days ago • Promoted
    Abbott - Head - TPMQA India Biosimilars

    Abbott - Head - TPMQA India Biosimilars

    Abbott Healthcare Pvt. Ltd. • Mumbai, India
    Primary Job Function : TPM's supplying to Biosimilars in India and APAC region.Quality Oversight of TPM's.Inspection readiness for Abbott audits and Regulatory audits for sites under respo...Show more
    Last updated: 29 days ago • Promoted
    Quality Assurance Manager

    Quality Assurance Manager

    Lykis Limited • Mumbai Metropolitan Region, India
    Maintain defined timelines for vendor approvals, ensure adherence to all compliance parameters, and monitor and compare key criteria such as cost, technical nuances, infrastructure, and overall pro...Show more
    Last updated: 15 hours ago • Promoted • New!
    Quality Assurance Manager (Patalganga Plant)

    Quality Assurance Manager (Patalganga Plant)

    Parle Agro Pvt Ltd • Mumbai, IN
    Graduation / PG in science - Food technology.Ensure quality of product as per company standards at optimal cost.Overall responsibility for implementing and reviewing Food Safety and Quality Manageme...Show more
    Last updated: 8 days ago • Promoted
    Plant Head

    Plant Head

    Blue Genes Research (BGR) • Mumbai, Maharashtra, India
    Hiring Now : Plant Head – Leading Manufacturing Group (India & Asia).Full-time | Leadership Role | Steel, Automotive, Precision, Tubes or pipes. On behalf of a renowned global manufacturing group, we...Show more
    Last updated: 23 days ago • Promoted
    Head of Quality

    Head of Quality

    Remal • Mumbai, Maharashtra, India
    We are seeking an experienced Head of Quality to lead the entire quality function for our Masteralloys, Castalloys, and Aluminium Billet division. The ideal candidate will have 10+ years of experien...Show more
    Last updated: 30+ days ago • Promoted
    Sales Head - Pharma

    Sales Head - Pharma

    Edme Insurance Brokers • Mumbai, Maharashtra, India
    Edme Insurance Brokers in looking for a leader to head sales under Pharma & Chemical sector.Interested candidates can reach out to : . Graduate / Postgraduate in any discipline (MBA preferred).Exposure...Show more
    Last updated: 11 days ago • Promoted
    Quality Assurance Technician

    Quality Assurance Technician

    Shoppers Stop • Mumbai, Maharashtra, India
    Quality Assurance Specialist is responsible to ensure that all external and internal requirements are met before our product reaches to our customers. He / she will be responsible for inspection proce...Show more
    Last updated: 30+ days ago • Promoted
    Head – TPMQA India Biosimilars

    Head – TPMQA India Biosimilars

    Abbott • Mumbai, Maharashtra, India
    Primary Job Function : TPMs supplying to Biosimilars in India and APAC region.Inspection readiness for Abbott audits and Regulatory audits for sites under responsibility. Investigations of Products f...Show more
    Last updated: 29 days ago • Promoted
    Head of Quality

    Head of Quality

    Randstad India • Mumbai, Maharashtra, India
    Looking to hire Head of Quality for a leading real estate developer in Mumbai.To lead the Quality function across all real estate multicity projects ensuring excellence in construction quality, com...Show more
    Last updated: 3 days ago • Promoted
    Plant Head ( Manufacturing industry Preferred)

    Plant Head ( Manufacturing industry Preferred)

    Thema Corporate Services • Navi Mumbai, Maharashtra, India
    Job Title : Plant Head – Cable Manufacturing.The Plant Head will be responsible for overseeing all daily operations of the cable. The role involves strategic planning, team leadership, compliance adh...Show more
    Last updated: 5 days ago • Promoted
    Lab QC (Quality Check) Head

    Lab QC (Quality Check) Head

    Amitex Agro Product Pvt. Ltd. • Mumbai, Maharashtra, India
    Founded in 2014 and headquartered in India,.Lecithin and Phospholipid ingredients.Our unwavering commitment is rooted in our mission : "Your Pathways to a Healthy Life. This guiding principle reflect...Show more
    Last updated: 1 day ago • Promoted