Job Description
Purpose
Qualification Review
Qualification and validation of Instrument and Equipment's, utility and facility
Qms
Evaluation of change control for new products, equipment, facility renovations, and utilities.
Support for deviations related to equipment and instruments.
Cleaning Validation
Monitor schedules for re-qualification, preventive maintenance, calibration, and validation.
Position / Job TitleAsst. ManagerDepartmentQuality Assurance – Qualification & validation of utility.Reporting ToManager- Quality Assurance LocationAmbernathYears of Experience4-7 Years Dosage FormSolid Oral / Nasal 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 etc
- 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 of SOP.Good at tracking and follow up activities.
- Tracking of qualification activity as per timeline. Through QMS documents.
- 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 Skills: B Pharmacy/ M. Pharmacy
- 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, Nasal.
- Team coordination and work distribution.
- Good communication skill which results to coordination with functions like QC, Manufacturing, Engineering, Warehouse Regulatory.
