Executive - Quality Assurance

**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 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 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  **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.