Job Description
- Responsible for Analyst qualification & QC employee training.
- Responsible for Preparation and review of Documents like Specification, STPs, TDS, SOP, COA. MTP, MVP, MVR, MTR.
- Responsible for Review of analytical data for routine samples (in process samples, DS, DP release and stability samples) method transfer and method validation.
- Responsible for management of reference standard and material indenting in QC.
- Responsible for Co-ordination with vendor for external calibration and with QC personnel for in- house calibration and verification of laboratory instruments.
- Responsible for maintenance and management of laboratory equipment and instruments.
- Responsible for managing method validation and method transfer activities.
- Responsible for initiation and investigation of incident, deviations, change control, OOS, CAPA and OOT.
- Responsible for analysis planning of DS, DP, Stability and protocol-based samples.
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