Quality Assurance Job at Zentiva, Ankleshwar
Want to build a career in pharmaceutical quality assurance and compliance with a global healthcare company? Zentiva is hiring a Quality Operations Specialist for its Ankleshwar, Gujarat location. This Quality Assurance Job at Zentiva Careers in Ankleshwar is ideal for professionals in Pharmacy, Medicine, Biotechnology, or Chemistry with experience in Quality Assurance or Regulatory Affairs in pharmaceutical manufacturing environments. The role focuses on Product Quality Reviews (PQRs), compliance management, quality tracking, stability data analysis, and coordination with cross-functional teams. Candidates will gain exposure to international pharmaceutical quality systems, GxP regulations, and compliance operations. This position offers strong career growth opportunities in pharmaceutical quality and scientific affairs.
About the Company:
Zentiva is an international pharmaceutical company focused on developing and supplying high-quality, affordable medicines across multiple therapeutic areas. The company operates globally with a strong emphasis on quality, compliance, sustainability, and patient-focused healthcare solutions. Zentiva promotes innovation, ethical practices, and continuous improvement across its pharmaceutical operations and manufacturing networks.
Job Details:
- Job Role: Quality Operations Specialist
- Location: Ankleshwar, Gujarat, India
- Department: Scientific Affairs
- Job ID: R2468955
- Employment Type: Full-Time
- Experience Required: 3–6 Years
- Industry: Pharmaceutical / Biotechnology / Quality Assurance
Key Responsibilities:
- Lead Product Quality Review (PQR) evaluations and review processes
- Ensure timely completion of PQR reviews as per the schedules in this Quality Assurance Job
- Maintain documentation, traceability, and compliance records
- Prepare trend analysis and KPI reports related to PQR activities
- Track quality review operations and compliance data
- Extract and compile analytical and manufacturing data from IT systems
- Collect and review stability data and product evaluation reports
- Coordinate meetings with cross-functional teams for issue resolution at Zentiva Careers
- Support deviation investigations and CAPA follow-up activities
- Communicate with Contract Manufacturing Organizations (CMOs)
- Participate in inspections and compliance activities
- Support third-party qualification and quality agreement reviews
- Assist in incoming batch control and regulatory communication processes
- Ensure compliance with cGxP, HSE, vigilance, compliance, and sustainability policies
Educational Requirements for this Job:
- Graduate or Postgraduate degree in Medicine
- 3–6 years of experience in Quality Assurance or Regulatory Affairs
- Minimum 3 years of experience in pharmaceutical manufacturing sites required
- Knowledge of stability regulations and pharmaceutical compliance required
Skills Required:
- Strong knowledge of GxP regulations and quality systems
- Experience with pharmaceutical quality operations
- Familiarity with IT tools such as SAP, eDMS, Share/DrugTrack, and Quality Forward
- Analytical and data interpretation skills
- Good organizational and documentation management abilities
- Strong communication and teamwork skills
- Decision-making and problem-solving capabilities
- Ability to manage priorities and work under pressure
- Understanding of CAPA, deviation handling, and compliance investigations
- Flexibility, adaptability, and attention to detail
Benefits of the Quality Assurance Job:
- Opportunity to work with a global pharmaceutical company
- Exposure to international quality assurance and compliance systems
- Career growth in Scientific Affairs and Quality Operations
- Experience with Product Quality Reviews and regulatory processes
- Cross-functional collaboration with global teams and CMOs
- Professional development in pharmaceutical manufacturing quality
- Learning opportunities in GxP, CAPA, and compliance management
- Participation in audits and inspections
- Exposure to sustainability and ESG-focused pharmaceutical practices
- Stable long-term career opportunities in the pharma industry
