Job Title: Quality Assurance Audit & Compliance Lead – Abbott EPD India
Main Purpose
To lead and manage the Quality Assurance Audit and Compliance function for Abbott EPD India. The role is responsible for ensuring that all suppliers (primarily third-party manufacturing sites), contract laboratories, and service providers comply with regulatory requirements and internal quality policies. This includes planning and executing audits, assessing compliance risks, ensuring timely closure of corrective actions, and driving continuous improvement across the audit function.
Key Responsibilities
1. Audit Planning & Execution
Develop and implement the annual audit schedule for suppliers, third-party manufacturers (TPMs), contract testing laboratories (CTLs), warehouses/distribution centers, and service providers.
Conduct “For Cause” audits to investigate significant quality issues and events.
Identify, document, and report quality and compliance risks, gaps, and deviations.
Review audit responses, monitor CAPAs, and ensure timely audit closures.
Collaborate with external vendors, contractors, and suppliers to ensure compliance with Abbott’s quality standards.
2. Documentation & Reporting
Maintain complete and accurate audit records in the Audit Management System.
Support preparation and publication of the Approved Supplier List (ASL).
Ensure adherence to global and local SOPs, regulatory guidelines, and internal quality requirements.
Contribute to management reviews and support key quality business processes.
Qualifications & Experience
Bachelor’s/Master’s degree in Pharmacy, Chemistry, or related field.
10–15 years of experience in Quality Assurance/Quality Control with strong exposure to pharmaceutical audits and compliance.
In-depth knowledge of GMP, global regulatory guidelines, and quality systems with the ability to evaluate all six manufacturing systems.
Proven expertise in third-party audits, supplier qualification, and compliance management.
Proficiency in audit documentation and management systems.
Demonstrated leadership, communication, and problem-solving skills.
Essential Soft Skills
Strong communication and interpersonal skills for effective stakeholder engagement.
Critical thinking and analytical approach to resolve complex compliance issues.
Conflict resolution and collaboration skills for managing external and internal partners.
Ability to coach, mentor, and work effectively across cross-functional teams.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Uttar Pradesh :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Birmingham |Virginia :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | Richmond Hill | Australia | Mississauga | Renfrew | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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King Abdullah Economic City | Rabigh | Khulais | Najran | Riyadh | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
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Midrand | South Africa |Nišava District :
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