Jubilant Bhartia Group

Long Description

Shall be responsible for the following activities:

• Overall responsibility for analytical compliance to in-line with current regulatory guideline, monograph requirements, customer requirements and in-house procedures.
• Review the Laboratory metrics, find out the scope of improvement for laboratory compliance. Find out the scope for right first time Laboratory performance.
• Review and approval of laboratory QMS like OOS, OOT, Deviation, Change management, Incidents, Action items, CAPA, Effectiveness Check, and relative documents in through in Trackwise / SAP system, as applicable.
• Review and approval of SOP, Specification, method of Analysis, General Testing Procedure and Analytical Work Order (analytical procedures)
• Ensure the completion of QMS events as per the timelines.
• Handling of Management and Customer notification.
• Involving the customer audit and regulatory audit. To carryout internal audits, CTL audit and unscheduled audits, as and when required.
• Review and approval of instrument qualification, Method validation/Method transfer/Method verification from QC.
• To impart training on Laboratory management and also as part of CAPA implementation.
• Review of Trending of quality events and establish the CAPA to prevent recurrence.
• Review and approval of risk assessment reports.
• Ensure implementation of cross-deployed CAPA and CAPAs resulting from regulatory assessment outcome in QC chemistry and Microbiology Labs.
• Responsible for carrying out any other assignment assigned by reporting manager.
• In the absence of the position holder tactical/operational responsibilities delegated by Job description holders Manager to his direct reports.

Long Description

Long Description

Long Description

Skills