Officer- Quality Assurance

3 days 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
- Release/rejection of Finished Products
- Working as a key user for management of SAP Athena QM module.
- Line Clearance and shop floor compliance
- Implementation of Zentiva Quality Directives, Management and Control of Documents, such as SOPs, Master Documents, etc.
- Implementation of Complaint Investigation system at site
- Handling of Qualification and validation system, change control system, deviations
- Preparing & review the Annual Product Quality Review
- Review of Batch Reworking/Reprocessing/Reincorporation Documents
- Review of Batch Manufacturing & Packing Records
- Coordination of cGMP Training activity including training of the people
- Handling of returned goods & recalls
- 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
- Review of the regulatory dossiers, as and when required
- Prepare for and attend to external / regulatory Quality audits
- Performing internal quality as a “Qualified Internal Auditor” during internal Quality Audit abiding the internal quality audit schedule
- Validations & Qualifications:

- Preparation, review and approval of Validation Master Plan
- Ensure validated status of all equipments, manufacturing processes, and cleaning processes
- Review of validation plans for facility / utilities / equipment / instrument / process / computer / cleaning
- Review of protocols for qualification and validation of facility/ equipment / product / process
- Review and certification of validation reports after execution of validation of facility /equipment / product / process
- Documentation Control:

- Preparation of quality system SOPs
- Controlled distribution and archival of documents & record
- Control of master documents
- Issuance of batch records and log books
- Assuring quality of products by:

- Ensuring SOP compliance
- Management of Events
- Controlling the changes made to facility / equipment / product / process and master documents by following change control procedure
- Investigation of Customer complaints / Recall
- 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
- Preparation of annual product quality review.
- Management of external manufacturing activity.
- cGMP Training:

- To develop training modules and organize training in GMP
- Develop and execute the overall training program in coordination with all concerned departments
- Other:

- Preparation and review of site master file
- Coordinating with various agencies for making of the technical agreements
- Implementing the pest control program at Drug products
- Review of maintenance and calibration program
- Supplier audit qualification and approval
- Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations

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