Quality Management/Continuous Improvement
- Handling and responsible for deviation & complaint Investigation
- Handling and responsible for batch release
- Management of Supplier Quality Assurance
- Handling of change control system
- Preparing & review the Annual Product Quality Review
- Coordination of cGMP training activity including training of the people
Documentation Control:
- Preparation of quality system SOPs
- Controlled distribution and archival of documents & record
- Control of master documents
- Management of archival room
- Issuance of batch records, ATR, logbooks and controlled formats.
Assuring quality of products by:
- In process controls
- 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
- Review of batch records & analytical testing records
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
Experience: 7 to 10 years in QA
