Recruitment for Pharmacy, Chemistry or Life Sciences at Zentiva

Zentiva is a producer of high-quality affordable medicines serving patients in Europe and beyond. With a dedicated team of more than 4 700 people and a network of production sites - including flagship sites in Prague, Bucharest, and Ankleshwar - Zentiva strives to be the champion of branded and generic medicines in Europe to better support people’s daily healthcare needs. At Zentiva it is our aspiration that healthcare should be a right and not a privilege.

Post : QA Specialist

The ESO Quality QA Specialist is responsible for the quality lifecycle management of an assigned subcontracted product portfolio and independent Quality Assurance oversight of assigned products and suppliers. The role ensures compliance with applicable Quality Management System, GMP, GDP and regulatory requirements and supports audits, product lifecycle activities and quality decision-making.

Job Description
• Operational quality management of an assigned product portfolio, including:
• Independently manage routine deviations, complaints and related CAPAs.
• Conduct Root Cause Analysis and follow up agreed corrective and preventive actions.
• Review and assess change controls and their Quality impact.
• Review GMP manufacturing documentation, analytical data, CoAs/CoCs and relevant batch documentation.
• Support batch release decisions through review of Quality documentation.
• Collect and independently review PQRs and stability data.
• Conduct routine Quality Risk Assessments.
• Review qualification and validation protocols and reports.
• Assess compliance of assigned third parties, suppliers and products.
• Review supplier Quality documentation and support supplier Quality management activities.
• Prepare and maintain Quality Agreements with third parties and subcontractors.
• Identify potential Data Integrity risks and escalate where appropriate.
• Provide QA support for product launches, transfers and lifecycle activities.
• Apply GMP, GDP, ICH and other applicable regulatory requirements independently.
• Prepare for and participate in external supplier audits, internal audits and inspections.
• Review audit reports and follow up agreed actions.
• Monitor Quality KPIs, analyse relevant data and support Quality decisions.
• Maintain product and Quality databases and use applicable QMS systems independently.
• Communicate effectively across functions and with external partners.
• Manage routine Quality discussions and negotiations with suppliers.
• Support onboarding, training and knowledge sharing within the team.

OTHER RESPONSIBILITIES
QUALITY
• Ensure full adherence to GxP principles and internal Quality standards
• Maintain compliance with applicable regulatory requirements

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.

COMPLIANCE
• The employee will comply with all internal policies and rules of the Company. The employee will make her/himself acquainted with Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents.

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..

Candidate Profile
• University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
• Knowledge of pharmaceutical GxP regulations and Quality system
• Strong understanding of GDP principles (EU GDP Guidelines).
• Experience in pharmaceutical quality systems or supply chain compliance.
• Experience working in dynamic, transformational environments.
• Ability to coordinate external service providers and internal stakeholders.
• Strong documentation, organizational, and communication skills.
• Experience in transformation, working in a dynamic environment.
• Collaborative and team-oriented
• Very good communication skills, and a customer-oriented approach.
• Flexibility and ability to manage competing priorities.
• Sense of urgency, high autonomy & stress resistance, agile personality
• Proven hands-on attitude, be flexible and adaptable, open minded.
• Open minded, positive, and energetic person
• Good Microsoft applications knowledge and computer skills
• Advanced knowledge of English

Additional Information
Qualification : University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
Location : Ankleshwar
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QA
End Date : 20th October 2026