PrimeVigilance, part of the Ergomed Group, is hiring experienced professionals for two Pharmacovigilance Quality Assurance (PV QA) positions in Pune, India. These openings are ideal for candidates with experience in Quality Management Systems (QMS), CAPA management, deviations, audits, inspections, and GxP compliance within the pharmaceutical, clinical research, or pharmacovigilance industry.
The company is currently recruiting for:
- Quality Specialist, Deviations & CAPAs
- Quality Specialist, Audit and Inspection Findings and CAPA
These PrimeVigilance jobs in Pune offer strong career growth opportunities in pharmacovigilance quality assurance, hybrid work exposure, global collaboration, and professional development.
PrimeVigilance Quality Specialist, Deviations & CAPAs โ Pune
Job Location
Pune, Maharashtra, India
Department
PV QM
Employment Type
Full-Time
Job Overview
The Quality Specialist, Deviations & CAPAs role focuses on ensuring deviations and Corrective and Preventive Actions (CAPAs) are managed efficiently while maintaining compliance with global pharmacovigilance regulations and internal quality standards.
Candidates with prior experience in Quality Assurance, CAPA handling, deviation management, and GVP compliance are encouraged to apply.
Key Responsibilities
- Lead administration, tracking, and management of deviations and CAPAs
- Support root cause analysis activities for deviations and CAPAs
- Manage deviation and CAPA workflows across teams
- Act as Subject Matter Expert (SME) for deviation and CAPA processes
- Support audits and inspections as quality representative
- Assist in deviation trending and quality metrics reporting
- Prepare compliance reports related to procedures and training
- Collaborate with global operational and quality teams
Required Qualifications
- Degree in Pharmacy, Nursing, Biomedical Sciences, Life Sciences, or related scientific discipline
- Previous experience in Quality and Compliance roles
- Pharmacovigilance (GVP) experience preferred
- Clinical research (GCP) exposure beneficial
- Experience with electronic Quality Management Systems preferred
- Strong MS Excel and MS Word skills
- Excellent English communication skills
PrimeVigilance Hiring Quality Specialist, Audit and Inspection Findings and CAPA โ Pune
Job Location
Pune, Maharashtra, India
Department
PV QA
Employment Type
Contract | Hybrid Mode
Job Overview
The Quality Specialist, Audit and Inspection Findings and CAPA role supports audit and inspection compliance activities while ensuring CAPAs are effectively implemented and maintained according to global GxP standards.
This PV QA role is suitable for professionals experienced in audit management, CAPA oversight, inspection readiness, and quality operations.
Key Responsibilities
- Support audit and inspection findings management
- Guide teams in CAPA development and implementation
- Ensure compliance with ICH, CIOMS, ISO, and GxP requirements
- Assist in training related to CAPA and inspection readiness
- Support Quality Management System improvement initiatives
- Prepare quality metrics and periodic management reports
- Participate in audit and inspection support activities
- Mentor and support quality team members globally
Required Qualifications
- Degree in Pharmacy, Nursing, Biomedical Sciences, Health Sciences, or related discipline
- Prior experience in Quality Assurance or Compliance preferred
- Strong understanding of GxP quality operations
- Fluency in English communication
- Ability to collaborate with global teams
Quality Specialist, Deviations & CAPAs:
Typically 2โ5 years experience in:
- Pharmacovigilance Quality Assurance (PV QA)
- CAPA and deviation management
- GVP/GCP compliance
- Quality Management Systems (QMS)
Quality Specialist, Audit and Inspection Findings and CAPA:
Usually 3โ6 years experience in:
- Audit and inspection support
- CAPA management
- GxP quality operations
- Regulatory compliance and QA activities
Why Join PrimeVigilance?
PrimeVigilance offers an employee-focused work culture with extensive opportunities for career growth in pharmacovigilance and quality assurance.
Employee Benefits
- Global work environment
- Internal training and development programs
- Career progression opportunities
- Supportive and collaborative culture
- Exposure to international pharmacovigilance operations
- Hybrid work flexibility for selected roles
- Strong focus on employee well-being and inclusion
Keywords Targeted
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How to Apply
Application Link Quality Specialist, Deviations & CAPAs
Application Link Quality Specialist, Audit and Inspection Findings and CAPA โ Pune
