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 & reviewing 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.
- 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, 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 & records.
- 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:
- Prepare training modules and organize training in GMP.
- Execute the training program in coordination with all concerned departments.
