Quality Assurance Associate
Location: Pune, Maharashtra, India
Job Type: Full-time
Department: PV QA
Company Overview
PrimeVigilance, part of the Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. With a global footprint across Europe, North America, and Asia, we deliver services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
We partner with small to large pharmaceutical and biotechnology companies, providing first-class, long-term support across all therapy areas, including medical devices. Our strong focus on training, development, employee well-being, and work-life balance ensures a high-quality service and a thriving team culture.
Role Summary
The QA Associate will support the Quality Assurance team to ensure that internal and external audits are planned, managed, and executed in line with PrimeVigilance procedures. This role involves facilitating audits and inspections, tracking CAPAs, maintaining QA documentation, and supporting compliance activities across the organization.
Key Responsibilities
Audit & Inspection Support
Host or support audits (routine, due diligence, qualification) and inspections by clients, third parties, and regulatory authorities.
Assist PrimeVigilance functional teams before, during, and after audits.
Manage audit scheduling requests from clients.
Maintain audit-related trackers and SharePoint repositories.
CAPA (Corrective and Preventive Action) Support
Track vendor audit CAPAs and monitor progress.
Facilitate and review vendor CAPA responses.
Maintain and update the global audit CAPA tracker.
Keep documentation from internal and vendor audits up to date.
Compliance & Risk Management
Assist in developing and maintaining internal risk assessments.
Support continuous improvement initiatives as requested by the Quality Audit Manager or Director of Quality.
Qualifications
University degree in a scientific discipline or equivalent industry experience.
Why Join PrimeVigilance
Training & career development opportunities.
Strong focus on personal and professional growth.
Supportive, collaborative, and diverse work environment.
Global team with English as the company language.
Core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships.
Estimated Salary Range: ₹4.5 – ₹7.5 LPA (based on experience)
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
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Brussels |Antwerp :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
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Manila |Croatia :
Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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