Quality Specialist, Deviations & CAPAs (PV - Quality Assuarance)
ERGOMEDPuneFull TimeEngineering
Remotely
gcppharmacovigilancequality management systemcapagvpdeviations
Job Description
📋 Description
- Lead the administration, tracking and management of Deviations (Devs) and CAPAs
- Support Subject Matter Experts to conduct root cause analysis
- Lead Devs and CAPAs through the workflow
- Provide support to operations and act as SME on Devs and CAPAs
- May participate in audits/inspections as Dev/ CAPA SME
- Prepare metrics on procedures and trainings for internal Quality & Compliance reporting
🎯 Requirements
- University degree in Biomedical/Natural/Health Sciences, Nursing, Pharmacy or related advanced
- Previous Pharmacovigilance (GVP) experience desirable
- Previous Clinical (GCP) experience beneficial
- Prior experience in a Quality and/or Compliance role required
- Experience with MS Office; Excel and Word advanced skills desirable
- Fluent in English (additional language is a plus)
🎁 Benefits
- Global pharmacovigilance environment with patient safety at the core
- Collaborative, flexible culture across regions
- Opportunities for growth and development within the PrimeVigilance/ERGOMED teams