Executive - Quality Assurance, Pharma

2 weeks ago

Ankleshwar, India Zentiva Group, a.s. Full time

Job Description for Executive - Quality Assurance, Pharma

Educational Qualification

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

Experience

- 3 to 5 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

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