Job Profile : For QC Profile
Designation : QC Head
Job Description :
- 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.
Interested candidate can email their resume at [email protected] | [email protected]
