ESO QA specialist

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