Review test results from the tests completed in the laboratory on pharmaceutical products.
Review of raw data, and review results generated in LIMS
Review the equipment calibration data and monthly calibration forms issuance and retrieval.
Review of instrument logbooks
Review of working standards consumption details in LIMS
Review of Analytical validation / Method transfer documents
Preparation of Certificate of Analysis.
Preparation and review of SOPs as and when required and tracking for their renewal.
Maintain SOPs, and compliance documentation.
Review/verification of sample entries in LIMS and verification of sample destruction
Support in investigation of quality events such as OOS/OOE/OOT/OOC/Incidence/Deviation and write up a report for the quality events observed.
Follow SOPs, good manufacturing practices and DI policies all the time while working on site.
Document management and control for the QC & QA departments
Ensure the specification and method of analysis is quarantined upon expiry and request for revised documents in timely manner.
Assist line manager in the external, internal audits and support for preparation.
Work with line manager and support in maintaining & improving Quality Management Systems.
Qualification requirements:
Graduate or Post-Graduate in Pharmaceutical Sciences, Science, Chemistry
> 5 years of experience in Quality Control/ Quality Assurance
Job Type: Full-time
Pay: 26,500.00-30,000.00 per year
Benefits:
Free parking
On-site parking
Work Location: In person
Reference ID: Compliance Officer
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