- Professional
- Escritório em Ankleshwar
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
