Officer- Quality Assurance

2 weeks ago

Ankleshwar, India Zentiva Group, a.s. Full time

**Education**:

- Graduate / Post Graduate in Pharmacy
- Experience:

- 0 - 3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory
- requirements
- Quality Management/Continuous Improvement
- Line Clearance and shop floor compliance
- Assisting in Complaint Investigation system at site
- Assisting in Qualification and validation system, change control system, deviations
- Preparing & review 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 existing system
- Preparing a compliance plan for closure of gaps
- Execution of compliance plans
- Review of completion for compliance activity
- Validations & Qualifications:

- Ensure validated status of all equipment’s, 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 & record
- Control of master documents
- Assuring 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
- Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations

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