Zentiva is inviting applications for the position of Executive I – Quality Assurance at its Ankleshwar, Gujarat manufacturing facility. This opportunity is ideal for candidates with 1–5 years of experience in Pharmaceutical Quality Assurance, Documentation, cGMP, GDP, Validation, and Quality Systems.
If you are a B.Pharm, M.Pharm, Pharmaceutical Sciences, or Life Sciences graduate seeking career growth in the pharmaceutical industry, this is an excellent opportunity to work in a highly regulated manufacturing environment with exposure to global quality standards.
Job Details
| Particular | Details |
|---|---|
| Company | Zentiva |
| Job Title | Executive I – Quality Assurance |
| Department | Quality Assurance |
| Location | Ankleshwar, Gujarat, India |
| Experience | 1–5 Years |
| Qualification | B.Pharm, M.Pharm, Pharmaceutical Sciences, Life Sciences or related discipline |
| Employment Type | Full-Time |
Key Responsibilities
The selected candidate will be responsible for maintaining pharmaceutical quality systems and ensuring compliance with cGMP and regulatory requirements.
Major responsibilities include:
- Perform line clearance and ensure shop floor GMP compliance.
- Conduct in-process quality checks and calibration of IPQC instruments.
- Operate electronic quality systems including SAP HANA, LIMS, eDMS and TrackWise.
- Support complaint investigations, deviation handling, change control and CAPA implementation.
- Prepare and review Annual Product Quality Review (APQR).
- Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
- Coordinate cGMP training programs across departments.
- Execute qualification and validation activities for equipment, facilities, manufacturing processes and cleaning validation.
- Prepare, review and control SOPs and quality documents.
- Maintain document control, archival and master document management.
- Review maintenance and calibration programs.
- Perform compliance gap analysis and implement corrective action plans.
- Ensure adherence to Local FDA, MHRA and company quality standards.
Required Qualifications
Applicants should possess:
- Bachelor’s or Master’s degree in:
- B.Pharm
- M.Pharm
- Pharmaceutical Sciences
- Life Sciences
- Related discipline
Experience Required:
- 1–5 years in Pharmaceutical Quality Assurance or Documentation.
Required Skills
Successful candidates should have knowledge of:
- Current Good Manufacturing Practices (cGMP)
- Good Documentation Practices (GDP)
- Pharmaceutical Quality Systems
- Batch Documentation
- Document Control
- APQR Preparation
- Regulatory Compliance
- Validation & Qualification
- Change Control
- Deviations & CAPA
- Data Integrity
- SOP Preparation
- SAP HANA
- LIMS
- eDMS
- TrackWise
- Cross-functional communication
- Analytical and organizational skills
Why Join Zentiva?
Working with Zentiva offers opportunities to:
- Build expertise in global pharmaceutical Quality Assurance.
- Gain exposure to regulatory inspections and compliance systems.
- Work with advanced electronic quality management tools.
- Develop validation and documentation expertise.
- Enhance professional growth within a regulated pharmaceutical manufacturing environment.
- Collaborate with experienced Quality Assurance professionals.