Executive - Quality Assurance, Pharma

Educational Qualification

• B. Pharm / M. Pharm from a reputed university
  

Experience

• 1 to 4 years of similar experience in a regulatory-approved OSD manufacturing large unit.
  

Quality Management/Continuous Improvement

Line Clearance and shop floor complianceAssisting in Complaint Investigation system at siteAssisting in Qualification and validation system, change control system, deviationsPreparing & review the Annual Product Quality ReviewReview of Batch Manufacturing & Packing RecordsCoordination of cGMP Training activity.

Compliance

Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by

Qualifications

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 processesReview of protocols for qualification and validation of facility/ equipment / product / processReview of validation reports after execution of validation of facility /equipment / product / process

Documentation Control

Preparation and Review of SOPsControlled distribution and archival of documents & recordControl of master documents

Assuring Quality Of Products By

Ensuring SOP complianceReview of Batch Manufacturing & Packing RecordsEnsuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaintsEnsuring the effectiveness review of the implemented CAPA

CGMP Training

To prepare training modules and organize training in GMPExecute the training program in coordination with all concerned departments

Other

Review of maintenance and calibration program