- To ensure cGMP in Quality Control laboratory.
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- Review of QC / QA documents.
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- Review and approve OOS, OOT, and Incident and Stability data of QC Laboratory.
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- To review and ensure effective implementation of regulatory requirement, guidelines and pharmacopeia changes like IP, BP, USP, Ph. Eur, JP etc.
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- To review of QC laboratory records on periodic basis.
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- To impart training to QC Laboratory personnel on SOPs, on-job training, regulatory requirements and guidelines.
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- To ensure monthly back-up of software data of all QC instruments.
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- To ensure compliance of AMC/PM visit for all QC instruments
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- To ensure compliance of Qualification and calibration planner for QC instruments.
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- To control and maintain QC Laboratory records (Issuance and archival of the documents like Laboratory note Book, Chromatograms, COA etc.).
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- To provide Quest data on monthly basis to concern person.
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- To perform self-audit of QC laboratory on periodic basis.
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- To take the responsibilities of the activity in absence of immediate superior.
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- To assign/disable password for QC laboratory analyst and to check audit trail in QC Instruments.
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- To assign/disable password for QC Biometric system.
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- Ensure compliance to KRA’s and other such assignments.
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- Analytical and Electronic data review of respective batches at the time of release.
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- Involving in Self Inspection activity at Site.
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- Document Submission/Regulatory submission to Customer regulatory department.
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- Document Submission to PEL Corporate Regulatory Affairs (CRA).
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- Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.
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