Group Leader

Routine planning of RM/PM/In-process/Intermediates/API & stability analysis.

Adhere to laid down QMS and ensure its effective implementation /facilitate continuous improvement in Quality Control & Microbiology Laboratories.

Actively participate in periodic review of key Quality control system procedures and ensure improvements to ensure productivity, compliance and all-time readiness.

Prepare and review of Investigations pertaining to OOS/OOT/OOC, market complaints, deviation Change controls/Internal audit responses/Document management system and CAPA activities in Track wise as and when required

Ensuring Change implementation as per plan and CAPA effectiveness verification.

Responsible for review of analytical records, electronic record and logbook.

Responsible as an auditee for internal audits, customer audits, regulatory audits and audit compliance

Responsible for Analytical Method validation, development, & transfers, Analyst qualification / Re-Qualification, Analytical standard and Column management, lab chemicals, solvents and other consumables related to QC.

Responsible for Preparation/Review of SOPs, Specification, Standard testing procedures, COA's protocols and other reports.

10.  Responsible for Release / Rejection materials in SAP.

11.  Responsible for evaluation of risk assessment activity involved in the quality events and improvement points.

12.  Review & approval of Instrument/Equipment Qualification Documents Computer system validation, Calibrations and validation reports.

13.  Responsible for handling and maintenance of stability and reserve sample management.

Participating in various new projects, discussions and ensuring that the facilities required for execution are available