Executive - QA

**Education**:

- Graduate / Post Graduate in Pharmacy or Chemistry
- Experience:

- 03-04 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements
- Quality Management/Continuous Improvement
- Handling of Deviations & CAPA
- Handling of Product Technical Complaints
- Review of Master Batch Manufacturing & Packing Records
- Release / rejection of Finished Products
- Management and Control of Documents, such as SOPs, Master Documents
- Issuance of BMR/BPR, log books and other controlled documents
- Management of Documentation room
- Preparing & review the Annual Product Quality Review
- Batch Rework/Reprocessing (Coordination from QA point of view)
- Coordination of cGMP Training activity including training of the people
- Handling of returned goods (Coordination from QA point of view)
- Handling of Self inspections
- Compliance to EN ISO 13485 requirements
- Validations & Qualifications:

- Preparation of Validation Master Plan
- Ensure validated status of all equipment, 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
- Sampling activity for validation batches
- Compliance:

- Ensure adherence to company Quality Standards, EU regulations and Local FDA 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 of compliance activity
- Prepare for and attend to external / regulatory Quality audits
- Assuring quality of products by:

- Ensuring SOP review and compliance
- Management of Events
- Controlling the changes made to facility / equipment / product / process and master documents by following change control procedure
- Investigation of deviations & Customer complaints
- Review of executed 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
- To approve the line clearance in manufacturing & Packing
- 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:

- Implementing the pest control program as and when required
- Review of maintenance and calibration program and calibration documents
- Review of quality control documents
- Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations