Executive I – QA at Zentiva
About Zentiva:
Zentiva, based in Prague, Czech Republic, is a leading pharmaceutical company specializing in developing, manufacturing, and marketing a wide range of generic and OTC products. With over 4,700 employees across Europe, Zentiva operates three manufacturing sites in Prague, Bucharest, and Ankleshwar.
Position: Executive I – QA
Organization: Zentiva
Qualification: B.Pharm, M.Pharm, MSc, BSc
Experience: Freshers (0 Years)
Salary: 2 to 5 LPA
Location: Ankleshwar, India
Key Responsibilities:
Quality Management/Continuous Improvement:
- Line clearance and shop floor compliance
- In-process checks and calibration of IPQC instruments
- Handling e-tools: SAP Hana, LIMS, eDMS, TrackWise
- Assisting in investigation, qualification, validation, change control, and deviation systems
- Preparing and reviewing Annual Product Quality Review
- Reviewing Batch Manufacturing & Packing Records
- Coordinating cGMP training activities
Compliance:
- Ensure adherence to company quality standards and local FDA/MHRA regulations
- Perform gap analysis and prepare compliance plans
- Execute compliance plans and review completion activities
Validations & Qualifications:
- Ensure validated status of equipment, manufacturing, and cleaning processes
- Review qualification and validation protocols
- Review validation reports post-execution
Documentation Control:
- Prepare and review SOPs
- Control distribution and archival of documents & records
- Control master documents
Assuring Quality of Products:
- Ensure SOP compliance
- Review Batch Manufacturing & Packing Records
- Implement and review CAPAs from deviations and customer complaints
cGMP Training:
- Prepare training modules and organize GMP training
- Execute training programs in coordination with departments