PrimeVigilance, a leading global pharmacovigilance service provider and part of the Ergomed Group, is inviting applications for the position of Quality Specialist, Deviations & CAPAs in Pune, India. This hybrid opportunity is ideal for professionals with experience in Quality Assurance, Pharmacovigilance (PV), Compliance, CAPA Management, and Quality Management Systems (QMS).
Candidates with qualifications in Pharmacy, Nursing, Biomedical Sciences, Life Sciences, Health Sciences, or related scientific disciplines are encouraged to apply. If you are looking to build your career in Pharmacovigilance Quality Assurance, CAPA Management, and Regulatory Compliance, this is an excellent opportunity to work with an internationally recognized organization.
Job Overview
- Company: PrimeVigilance (Ergomed Group)
- Job Title: Quality Specialist, Deviations & CAPAs
- Location: Pune, Maharashtra, India
- Work Mode: Hybrid
- Department: PV Quality Management
- Employment Type: Full-Time
Key Responsibilities
The selected candidate will be responsible for:
- Leading administration and lifecycle management of Deviations and CAPAs.
- Tracking CAPAs to ensure timely completion.
- Supporting Subject Matter Experts during Root Cause Analysis (RCA).
- Managing deviation and CAPA workflows through the Quality Management System.
- Providing expert guidance on deviation and CAPA processes.
- Supporting internal and external audits and regulatory inspections.
- Performing trend analysis of deviations across the organization.
- Preparing quality metrics, compliance reports, and training reports.
- Collaborating with cross-functional Quality and Compliance teams.
- Ensuring compliance with global pharmacovigilance regulations and company SOPs.
Eligibility Criteria
Applicants should possess any of the following qualifications:
- B.Pharm
- M.Pharm
- B.Sc (Life Sciences)
- M.Sc
- Nursing
- Biomedical Sciences
- Health Sciences
- Natural Sciences
- Equivalent scientific degree
Preferred Experience
Candidates with experience in the following areas will be preferred:
- Quality Assurance (QA)
- Quality Compliance
- CAPA Management
- Deviation Management
- Pharmacovigilance (GVP)
- Clinical Research (GCP)
- Medical Information
- Medical Devices
- Electronic Quality Management Systems (eQMS)
Required Skills
- Strong understanding of CAPA and Deviation Management
- Root Cause Analysis (RCA)
- Pharmacovigilance Quality Management
- Excellent documentation skills
- Advanced Microsoft Excel and MS Word
- Good analytical and communication skills
- Fluent English
Why Join PrimeVigilance?
PrimeVigilance offers employees:
- Hybrid working model
- Global career opportunities
- Structured training and professional development
- International work environment
- Exposure to global pharmacovigilance operations
- Inclusive and diverse workplace
- Supportive culture focused on employee wellbeing
- Long-term career growth opportunities
Who Should Apply?
This role is suitable for professionals working in:
- Pharmacovigilance
- Quality Assurance
- Drug Safety
- Regulatory Affairs
- Clinical Research
- Medical Information
- Compliance
- CAPA & Deviation Management
How to Apply
