MSc Chemistry Job at Zentiva | Quality Specialist Role
Are you looking for an MSc Chemistry Job in the pharmaceutical industry? Zentiva is hiring a Quality Specialist for its Ankleshwar, Gujarat location. This Quality Operations Specialist role is ideal for candidates with 3–6 years of experience in Quality Assurance or Regulatory Affairs within pharmaceutical manufacturing. Professionals with strong GxP knowledge, PQR review experience, and compliance expertise can advance their careers in global pharma quality operations.
About Zentiva
Zentiva is a leading European pharmaceutical company dedicated to developing, manufacturing, and delivering high-quality, affordable medicines across multiple international markets. With a strong presence in generics and specialty pharmaceuticals, Zentiva operates state-of-the-art manufacturing facilities that comply with global regulatory standards and cGxP guidelines. The company emphasizes quality, compliance, sustainability, and patient safety across its operations. For professionals seeking an MSc Chemistry Job or a Quality Specialist role, Zentiva offers excellent career growth opportunities in pharmaceutical quality assurance, regulatory compliance, and scientific operations within a globally connected organization.
- Job Title: Quality Operations Specialist
- Location: Ankleshwar, India
- Job Requisition ID: R2468955
Role Overview
The Quality Operations Specialist supports the Quality Assurance and Compliance function of Zentiva to ensure compliance with applicable requirements and Corporate Zentiva
guidelines. The role involves leading a periodic review of products commercialized in Portugal.Mandatory Requirements
- Graduated / post-graduate in Pharmacy/Medicine or Chemistry/Biotechnology
- 3 to 6 years minimum experience in Quality or Regulatory Affairs
- Experience obtained in pharmaceutical manufacturing sites (+3 years).
- Knowledge of stability regulations and their application to the industry
- Skilled in the usage of IT tools (for example: Quality Forward, Share/DrugTrack, eDMS), SAP.
- English speaker
- Good organizational skills, stress resistance, and flexibility
- Good Team player and good at decision-making
- Interpretation/Analytical data.
- Experience in the pharmaceutical/biotech industry with a good level of GxP know-how is a strong plus.
- Reactivity, autonomy, with a sense of urgency and priorities.
- Open-mindedness and team spirit.
Main Responsibilities
- Lead responsibility for Product Quality Reviews (PQR) review completion for the cases in which Zentiva Portugal is the marketing authorization holder (MAH).
- Ensure traceability of the evaluation (report) is always available according to Zentiva Italy procedures.
- Flag and escalate delays to the Zentiva Italy Quality & Compliance Manager.
- Prepares trends analysis and KPI on the PQR review process.
- Ensure maintenance of a document for tracking of PQRs review operations and support periodic reporting.
- Calculate PQRs review KPIs on a monthly basis.
- Extract and compile analytical and regulatory data from IT tools.
- Collect stability data and reports for product-related evaluations.
- Schedule meetings with transversal functions for clarifications or to assign follow-up action items.
- Support PQR review related deviation investigations.
- CAPA plan follow-up on PQR-related issues with transversal functions and communicate with CMOs.
- Participate in inspections.
- Support in the review of the qualification status of the Zentiva Italy third parties and management of incoming batch controls.
Other Responsibilities
- Quality: Comply with cGxPs and Zentiva’s Quality Standards.
- HSE: Comply with Zentiva ESMS Policy for Occupational Health and Safety and Environmental regulations.
- Vigilance: Report adverse events and safety information related to ZENTIVA products.
- Compliance: Observe the Company’s rules and policies, adhering to the Code of Ethics.
- Sustainability: Adhere to ESG principles in Zentiva’s Sustainability Strategy.
