Officer
Job Description
PurposeHandling Deviations, Customer Complaint investigations, Support in Audit and Compliance Management, Handling of ǪMS documentationPosition/JobTitleQA officerDepartmentQuality AssuranceReportingToSection Head – QMSLocationSataraYears of Experience2-5 YearsDosageFormLiquid / PotentJobResponsibilities/ Deliverables- Handling Deviation, Customer complaint documentation, participating in investigation, and drafting investigation reports.
- Responding to customer communications and queries.
- Preparation and review of SOPs applicable for customer complaint and other job-related SOPs.
- EvaluationofǪMSdocuments.
- PreparationofSiteMasterFile.
- Participate in customer and regulatory inspections and ensure customer complaint CAPA effectiveness.
- Participate in self-inspections.
- To audit the internal quality systems a part of self-inspection (internal audit).
- PreparationofpresentationsandMOMforManagementReviewMeetings,weekly report and follow-up for action closures.
- CarryoutSAPtransactionsforcodecreationsandmasterupdating.
- Timelyandproactivelyescalatingissues.
- B. Pharm / M. Pharm / M.Sc. (Chemistry)With relevant experience in pharma quality assurance
- Sound knowledge of QMS activities
- ExposuretovariousregulatorybodiessuchasUSFDA,EU-GMP,MHRA,TGA.
- Familiarity with Liquid Oral dosage forms and/or potent formulations, OSD (optional)
- Effective communication, Team coordination and work in collaboration
within compliance
Additionalnotes- Role is expected to work in all shifts and all days of the week.
- Flexibility to take on additional responsibilities as assigned by management