Executive - Quality Assurance (Pharmaceuticals)

Job Title- Executive Quality Assurance (Pharmaceuticals)

• Educational requirement
• B.Pharm or M.Pharm with 1-5 years of experience.

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 .