93+ Applicants
Posted: 1 week ago
2-5 years
Thane, Maharashtra
work from office
Posted: 1 week ago
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Applicants: 93+
Job Description
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Job Description
PurposeHandling Deviations, Customer Complaint investigations, Support in Audit and Compliance Management, Handling of ?MS documentationPosition/JobTitleQA officerDepartmentQuality AssuranceReportingToSection Head QMSLocationSatara
Years of Experience2-5 YearsDosageFormLiquid / PotentJobResponsibilities/ Deliverables
Additionalnotes
- 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.
- Evaluationof?MSdocuments.
- 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.
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- 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
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
Skills
AuditCompliance ManagementAssuranceInternal AuditCapaGmpInvestigationMhraQaQmsQuality SystemsQuality AssuranceReportingSopsIf an employer asks you to pay any kind of fee, please notify us immediately. Jobaaj does not charge any fee from the applicants and we do not allow other companies also to do so.
Important dates & deadlines?
Application Deadline
03 Apr 26, 01:55 PM IST
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