Quality Specialist Job at Zentiva | Chemical Science Graduates Apply Now
Looking for a strong Quality Specialist role in the pharmaceutical industry? This Quality Operations Specialist position at Zentiva Career in Ankleshwar is an excellent opportunity for professionals from Chemistry, Pharmacy, Biotechnology, and Chemical Science Career backgrounds. Candidates with expertise in GMP systems, regulatory compliance, and pharmaceutical quality operations can apply for this Chemical Science Career opportunity. The role involves Product Quality Reviews, CAPA management, and data-driven quality assurance within a global pharma environment.
About Zentiva
Zentiva is a globally recognized pharmaceutical company focused on delivering high-quality and affordable medicines. Zentiva Career opportunities are designed for professionals passionate about pharmaceutical innovation, compliance, and quality excellence. The company operates with strong GMP frameworks and regulatory standards, offering a dynamic environment for Chemical Science Career professionals to grow in quality systems, manufacturing compliance, and global pharmaceutical operations.
- Job Post: Quality Operations Specialist
- Locations: India / Ankleshwar
- Job requisition ID: R2468955
Job Overview
Zentiva is hiring a Quality Operations Specialist / Quality Specialist at its Ankleshwar facility in Gujarat. This role is part of the Scientific Affairs and Quality & Compliance department. The selected candidate will manage Product Quality Reviews (PQR), ensure compliance
with regulatory standards, and support pharmaceutical manufacturing quality systems. This Chemical Science Career role requires handling stability data, SAP systems, and cross-functional quality coordination across global teams.Requiremnets
- 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.
Responsibilities
- Reporting to Zentiva Italy Quality & Compliance Manager, the Quality Operations Specialist will take lead responsibility for Product Quality Reviews (PQR) review completion for the cases in which Zentiva Portugal is the marketing authorization holder (MAH).
- Responsible for meeting the established schedule in completing the reviews of PQRs.
- For each evaluated PQR, the Quality Operations Specialist will ensure that the traceability of the evaluation is always available.
- Responsible for flagging/escalating any delays on time.
- Prepares trends analysis and KPI on the PQR review process.
- Responsible for ensuring the maintenance of an up-to-date document for tracking of PQR review operations.
- Responsible for calculating PQRs review KPIs on a monthly basis.
- Responsible for the extraction and data compilation of analytical and manufacturing data.
- Responsible for collecting stability data and reports for product-related evaluations.
- Responsible for scheduling meetings with transversal functions for clarifications or follow-up actions.
- Support the PQR review-related deviation investigations.
- CAPA plan follow-up on PQR-related issues.
- Participate in inspections.
- Support the review of the qualification status of suppliers and Zentiva entities when requested.
- Support the management of incoming batch controls, including quarantine arrivals and scraps communication to the authority.
This Quality Specialist opportunity at Zentiva Career is a strong Chemical Science Career path for professionals seeking growth in pharmaceutical quality systems and compliance roles. The position offers exposure to global GMP standards, PQR systems, and regulatory frameworks. Candidates with experience in Pharma Quality Assurance Careers can build a stable and impactful career in the pharmaceutical industry through this Ankleshwar-based opportunity.
