To review and participate in an investigations of OOS/ OOT and incidents/Deviation to found out the root cause and ensuring the adequacy of investigation, documentation and CAPA.
To review of electronic generated data and audit trail for various server based and stand-alone systems viz. LIMS, HPLC, GC, UV, etc. to ensure data integrity and compliances.
To review and approval of stability sample management, Stability protocols and reports.
To review and approval of Analytical method validation, method transfer protocols and reports.
To review and assessment the change control, temporary change control and deviation.
To review and approval of specification, STPs, GTPs and analytical Lab related SOPs and implement the pharmacopoeia changes.
To prepare & review of software validation documents like URS, IRA, FS, FRA, OQ & PQ as per regulatory requirement.
Post implementation & Periodic review of GxP system to keep the system compliant as per GAMP 5, 21 CFR part 11 requirements.
Preparation of corporate policies, standard practices & directives as per Regulatory amendments and ensure the implementation of the same.
Sound working knowledge in SAP QM, PM, MM module.
Implementation & reviewing of quality systems, standards and procedure be followed as per cGMP, GDP, GLP, other regulatory guidelines.
To monitor and validate the computer system followed by referring GAMP 5 Guideline, PIC/s 2011, 21 CFR Part 11, EU Annexure 11, Schedule M and MHRA Guideline on Data Integrity.
To evaluate and perform gap analysis of FDA 483s, warning letters and regulatory observation.
Involvement in the regulatory audit of the quality system and initiation as well as follow up action of corrective action if any.
Planning and work allocation as per requirement and schedule.

QC Head

Job Description

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