ESO QA Specialist

Zentiva Poland; India; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Zentiva is seeking an ESO QA Specialist in India to manage quality for a dedicated product portfolio, handling deviation and complaint records, CAPAs, change controls, and third‑party compliance, while supporting audits and product transfers.

The ideal candidate has a life sciences degree, 5+ years in GMP settings, strong IT tool knowledge, excellent communication and negotiation skills, and a proactive, collaborative attitude.

Qualifications

• University degree in Pharmacy, Chemistry, Biology, or Life Science.
• Minimum of 5 years in a GMP related environment.
• Thorough knowledge of GMP, ICH and regulatory requirements.
• Experience managing subcontractors is an advantage.
• Proven project management skills with strong communication and negotiation abilities.
• Proactive, problem solving mindset; collaborative and team-spirited.
• Knowledge of IT tools and fluent English.

Responsibilities

• Quality management of deviation and complaint records and CAPAs.
• Assessment and management of change controls.
• Edition of QA Agreements with Zentiva third parties and subcontractors.
• Collection and review of CoA/CoC; support product launches and transfers.
• Auditing: prepare audit plans, conduct external and internal audits, evaluate reports.
• KPI monitoring and reporting; maintain product database.
• Ensure GMP, GDP, MDR, HACCP, Cosmetics regulations compliance.

Skills

Quality management

GMP knowledge

Project management

Communication skills

Problem solving

Team collaboration

IT tools

English proficiency

Education

University degree in Pharmacy, Chemistry, Biology, or Life Science

Tools

IT tools

Job description

## ESO QA SpecialistPresenta candidaturalocations: India / Ankleshwartime type: Full timeposted on: Offerta pubblicata oggijob requisition id: R2468995**MAIN ACCOUNTABILITIES AND DUTIES*** Operational skillsOperational 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 type and scope of work.**OTHER RESPONSIBILITIES****QUALITY*** Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.**HSE*** Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.**PHARMACOVIGILANCE*** All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations**COMPLIANCE*** The employee will comply with all internal policies and rules of the Company. The employee will make her/himself acquainted with the Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents.**REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS*** University degree in Pharmacy, Chemistry, Biology, or relevant Life Science* Minimum of 5 years in a similar role or equivalent experiences 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