ESO QA specialist

2 weeks ago

Ankleshwar, Gujarat, India Zentiva Full time ₹ 15,00,000 - ₹ 28,00,000 per year

Position title: ESO QA Specialist

  • University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
  • Minimum of 5 years in a similar role or equivalent experience in a GMP-related environment

Job location - Ankleshwar, Gujarat, India

MISSION STATEMENT

To ensure the quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor.

MAIN ACCOUNTABILITIES AND DUTIES

Operational skills

Operational quality management of a dedicated product portfolio which includes:

  • Quality management of deviation and complaint records and their related CAPAs
  • Assessment and management of change controls
  • Edition of QA Agreements with Zentiva third parties and subcontractors
  • Collection and evaluation of PQRs and stability data
  • Compliance evaluation of Third Parties and products
  • Maintenance of product database
  • Collection and review of CoA/CoC
  • QA support of product launches and transfers
  • GMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislations

Auditing

  • Prepare audit and audit plans
  • Conduct and participate to external audits
  • Evaluation of audit reports
  • Participate to internal audits and inspections

KPI monitoring and reporting

Other tasks may be performed under the direction of the Manager within the agreed-upon type and scope of work.

REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS

  • University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
  • Minimum of 5 years in a similar role or equivalent experience in a GMP-related environment
  • Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements
  • Management of subcontractors is an advantage
  • Proven track record of project management skills
  • Strong communication skills and negotiation strength
  • Proactive attitude
  • Problem-solving skills
  • Hands-on attitude, flexible and open-minded
  • Collaborative and team-spirited
  • Knowledge of IT tools
  • Language - English: Advanced level

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