Am - Quality Assurance (Pharmaceuticals)
4 days ago
Education:
Graduate / Post Graduate in Pharmacy or Chemistry
**Experience**:
07-08 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
- External Job Description
External Job Description
**Education**:
Graduate / Post Graduate in Pharmacy or Chemistry
**Experience**:
07-08 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 an
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