Dy Mgr / Mgr - QC (Reviewer)

Bioksha

Required skills

Website: bioksha.in
Job details:
Key Responsibility area /Activities

Documentation & Review of analytical data (RM, PM, SFG, FG, Stability,Hold time, PV, CV, WS, Water, Volumetric solutions,Calibration etc.,) hard copy and as well as electronic data (LabWare LIMS, Empower and other instrument software).
Verification of instrument usage logbook and e-Logbook
Review of certificate of analysis.
Online review of electronic data and documents.
To review / Approve instrument methods created on Empower and other standalone instruments.
To review the electronic data in LabWare LIMS.
To review the audit trail of computerized systems
Review of Stability Study Records and summary reports.
Handling of Issuance, retrieval, destruction of QC activity related formats / Investigation formats / log books / Specification.
Preparation and review of Standard Operating Procedures
Any additional activity assigned by Head of the Department

Investigations

To inform, initiate and participate in investigation of laboratory Incident, out of specification results,significant change, OOC and OOT related to analytical results obtained in the Quality Control Department

Lab Compliance

To ensure the lab compliance as per the applicable cGMP, regulatory guidelines and SOPs.
To perform and prepare the gap assessment /Risk assessment
To participate in internal / external audits.
To monitor analyst practices.
To ensure the implementation of CAPAs taken as part of improvement.

Continuous Improvement

To attend training as per ATP schedule and on all mandatory topics.
To conduct SOP training and ensure all training needs are met.
To provide technical and functional guidance / support to subordinates / colleagues.
Keep self-updated to developments and advances in related field of work
To ensure the right first time activity
To identify and recommend continuous improvements initiatives, adopt best practices and motivate team

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