Executive - Quality Assurance (Pharmaceuticals)

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 Complaint 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 EU, 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 .