ESO QA specialist

1 week ago

Ankleshwar, India Zentiva Group, a.s. Full time

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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