HomeHead/VP/CEO/President/GMManager Quality Assurance | Abbott India | Mumbai

Manager Quality Assurance | Abbott India | Mumbai


Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

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The people of Abbott come to work each day with relentless energy, enthusiasm, and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Position: Manager Quality Assurance

Location: BKC Building, Mumbai, Maharashtra

Job Description:

  • Warehouse/ CFA Audit:

•  Creating and maintaining warehouse / CFA audit schedule
•  Conducting audits as per schedule
•  Tracking and closure of audits

  • Creating & maintaining warehouse / CFA training schedule and executing the same
  • Tracking and timely closing CAPA on identified action points arising out of:

•  Abbott Affiliate Audit
•  Regional Supplier Audit
•  Regulated monitoring activities
•  Exceptions

  • Identification, preparation, review, and updating of Distribution Quality SOPs/ Quality Manual/ documents meeting requirements of regulatory and Abbott (Corporate & Divisional documents)
  • Ensuring over labeling controls at approved Overlabelling facilities in line with Abbott standards
  • Verification of artwork proofs of Avene / PFDC products (direct import and market) against approved artwork and release the same
  • Uploading and reviewing data loggers of cold chain products into Global software and further sharing approvals to import department
  • Leading distribution quality excellence activities at EPD India region
  • Influvac Management
    • Tracking and confirming reference standards availability by coordination with import department
    • Ensuring on-time toxicity testing from the approved public testing lab for every consignment
  • Maintenance of Product List of EPD – India
    • Updating product list on a monthly basis, by coordinating with plants & TPM QA on technology transfers, FLQRs or any other changes of the month
    • Summarize and share the list of changes in Global format for updating in SolTRAQs
    • Maintaining and sharing product list on a quarterly basis to internal stakeholders as well in compliance with Quality Manual
    • Sharing updated product list/addendum to storage condition list to Distribution team
      HO Functions
  • Ensure compliance with Audit observations related to SAP and Distribution Quality of:
    •US finance audit
    •Consortium Audits/AQR audits
  • SAP activities
    • Overseeing SAP activities and ensuring correctness and compliance of the activity
      Consortium Audit at Warehouses / CFAs
  • Ensuring no major or critical observations in Consortium audits related to Distribution quality
  • Ensuring acceptable CAPA availability and timely closure of CAPAs of audit observations
  • Performing any additional tasks assigned by the Reporting Manager after completion of the necessary training

Qualification: M.Pharma

Experience & Expertise:

  • 12-16 years of relevant experience in Distribution Quality Assurance of Pharmaceutical Products meeting Good Distribution Practices
  • Experience in Quality Auditing of Warehouse/ CFA. Auditor certification (i.e. by ASQ/ ISO) is plus
  • Experience in Training people on GXP topics
  • Experience in handling GXP software such as TrackWise, SAP, etc.
  • Experience in managing a team
  • Able to coordinate with cross-regional/divisional colleagues from geographically and culturally diverse teams while involving various projects

Desired Skills: Excellent communication skills, managerial skills, convincing skills, negotiation skills, and presentation skills

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