Job Description for 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 compliance
Assisting in the Complaint Investigation system at site
Assisting in the 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, by
Understanding the requirements Performing the Gap analysis to find out the gaps in the existing system Preparing a compliance plan for the 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 & 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
