Executive I - QA

Quality Management/Continuous Improvement

• Line Clearance and shop floor compliance
• Carry out in-process checks and calibration of IPQC instruments .
• Handle e tools i.e. SAP Hana, LIMS, eDMS , Track Wise system.
• Assisting in Investigation system at site
• Assisting in Q ualification 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

Validation s & 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 distributi on 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/Preventiv e 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
• E xecute the training program in coordination with all concerned departments

Other:

• Review of maintenance and calibration program
• Experience: 2 to 5 years in QA