Job Description
Qualification Review:
Qualification and validation of Instrument and Equipment's, utility and facility
Cleaning Validation
Conduct worst-case assessments.
Perform MACO calculations, and prepare protocols and reports tracking
Activity Tracking
Monitor schedules for re-qualification, preventive maintenance, calibration, and validation.
Position / Job Title - Executive
Department - Quality Assurance – Qualification, Cleaning validation
Reporting To - Senior Manager- Quality Assurance
Years of Experience - 5-8 Years
Dosage Form - Solid Oral
Location - Pithampur
Job Responsibilities / Deliverables -
- Well versed in the qualification document review which includes review of
- URS, FDS, FRA, DQ, IQ, OQ, and PQ
- Risk assessment,
- GAP assessment
- CSV
- Executed document review
- Well versed in the cleaning validation document review which includes review of
- change request evaluation with respect to change in API, manufacturing process, equipment cleaning procedure, change in equipment train
- Risk assessment with respect to change in cleaning process, new equipment introduction,
- GAP assessment with respect to current regulatory requirement
- Cleaning validation worst-case assessment, MACO calculation, protocol and report preparation.
- Tracking of cleaning validation scheduled activity
- Ensure all QMS are closed as per SOP timeline.
- Review of calibration activity as per defined schedule frequency.
- Review of preventive maintenance activity as per defined frequency.
- Review of requalification activity as per defined frequency.
- Preparation and review of QA department SOPs.
- Tracking of qualification and requalification activities and follow up activities.
- Independently handle qualification and validation activity.
- Good co-ordination skills with another department.
- Good knowledge about current trends of Data integrity.
- Good knowledge about current Regulatory Guidance and requirement
Qualifications & Pre-Requisites
Must have knowledge on handling Qualification and validation.
Exposure to various regulatory bodies like US FDA, MHRA, TGA.
Exposure to specific dosage forms like OSD.
Team coordination and work distribution.
Good communication skill which results to coordination with functions like QC, Manufacturing, Engineering, Warehouse Regulatory.
