Search by job, company or skills

  • Posted 2 months ago
  • Be among the first 10 applicants
Early Applicant

Job Description

PurposeHandling Deviations, Customer Complaint investigations, Support in Audit and Compliance Management, Handling of MS 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.
  • EvaluationofMSdocuments.
  • 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.

Qualifications& Pre-Requisites

  • 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

More Info

Job Type:
Industry:
Employment Type:

Job ID: 141051603