Quality Assurance Job at Zentiva | Pharma Graduates Apply Now for the Officer Role
Zentiva is hiring an Officer – Quality Assurance (Pharmaceuticals) for its regulatory-approved OSD unit in Ankleshwar, Gujarat. This Quality Assurance Job is ideal for B.Pharm or M.Pharm graduates with 1 to 4 years of experience in a large-scale pharma environment. The successful candidate will lead shop floor compliance, IPQA (Line Clearance), and assist with critical Quality Management Systems (QMS) such as Deviations, Change Control, and CAPA, while ensuring adherence to USFDA and MHRA regulations.
- Position Title: Officer- Quality Assurance (Pharmaceuticals)
- Location: India / Ankleshwar
- Job Requisition ID: R2468772
About The Company
Zentiva is a leading pan-European manufacturer of high-quality, affordable generic medicines, with a heritage dating back over 500 years. Headquartered in Prague, Zentiva operates a major manufacturing hub in Ankleshwar, Gujarat, which is one of its largest global sites specializing in Oral Solid Dosage (OSD) forms. This facility is highly regulated and carries approvals from the USFDA, MHRA, and EMA, serving as a strategic pillar for Zentiva’s mission to provide high-quality healthcare to millions of patients across Europe and beyond.
Educational Qualification
- B. Pharm / M. Pharm from a reputed university
Experience
- 1 to 4 years of similar experience in a regulatory-approved OSD manufacturing large unit.
Quality Management/Continuous Improvement
- Line Clearance and shop floor compliance
- Assisting in the Complaint Investigation system at the site
- Assisting in the Qualification and validation system, change control system, and deviations
- Preparing & reviewing the Annual Product Quality Review
- Review of Batch Manufacturing & Packing Records
- Coordination of cGMP Training activity.
Compliance
- Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by:
- Understanding the requirements
- Performing the Gap analysis to find out the gaps in the existing system
- Preparing a compliance plan for the closure of gaps
- Execution of compliance plans
- Review of completion for compliance activity
Validations & Qualifications
- Ensure the validated status of all equipment, manufacturing processes, and cleaning processes
- Review of protocols for qualification and validation of facility/equipment/product/process
- Review of validation reports after execution of validation of facility/equipment/product/process
Documentation Control
- Preparation and Review of SOPs
- Controlled distribution and archival of documents & records
- Control of master documents
Assuring the quality of products by
- Ensuring SOP compliance
- Review of Batch Manufacturing & Packing Records
- Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
- Ensuring the effectiveness review of the implemented CAPA
cGMP Training
- To prepare training modules and organize training in GMP
- Execute the training program in coordination with all concerned departments
Other
- Review of maintenance and calibration program.
