Senior Executive - 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 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