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Senior Quality Assurance Expert

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Chandigarh, Chandigarh, India beBeeQuality Full time ₹ 23,04,000 - ₹ 25,92,000
Quality Assurance Role

The ideal candidate for this position will possess a strong background in quality assurance, with experience in Pharmacovigilance (PV) and GCP auditing.

This individual will be responsible for managing quality issues, developing CAPA plans, and performing internal audits to ensure compliance with applicable GVP and GCP requirements.

The Quality Assurance Specialist will be responsible for the following activities:

  • Management of quality issues/events/deviations and CAPAs
  • Performing RCAs and/or providing guidance to staff in performing RCAs
  • Developing CAPA plans and/or providing guidance to staff in developing and implementing CAPAs
  • Planning audits using a risk-based assessment and maintaining the audit planner
  • Preparing audit schedules and performing internal audits and audits of vendors
  • Maintaining/managing controlled documents such as SOPs, templates etc.
  • Liaising with Project Leads/Functional Heads for ensuring implementation of applicable KPIs/metrics
  • Reviewing the quality and compliance data of various projects; performing trend analyses and interpretation of analyses

Key Requirements

  • Degree in any of the Life Sciences disciplines (Pharmacy, Microbiology, Biochemistry, Biotechnology etc.)
  • Experience of 5-6 years in PV and/or GCP and Quality Assurance
  • High level of proficiency in English, particularly written English
  • Auditing certification (e.g. ISO lead auditor/assessor certification)
  • Auditing experience, specially planning for audits using risk-based approach
  • Experience in performing RCAs and development of CAPAs
  • Working knowledge of drug safety/GCP/regulatory requirements
  • Strong written and verbal communication skills
  • Detail oriented
  • Passion for delivering high quality work
  • Ability to manage multiple and varied tasks effectively
  • High level of flexibility and ability to prioritize work
  • Ability to perform under stringent timelines
  • Ability to work independently or as a team member
  • Excellent problem-solving skills and decision-making skills
  • Ability to understand, interpret, analyse and present data
  • Computer proficiency: proficiency in the use of MS Office suite (Word/Excel/PowerPoint)
  • Ability and willingness to travel, as needed