16 Aug
|
USV
|
Govandi East
Role Objective:
The primary objective of this role is to manage and oversee Quality Management System (QMS) documentation, audits, and compliance activities at a corporate level. The incumbent will ensure that all manufacturing sites and contract testing laboratories (CTLs) adhere to established protocols, regulatory requirements, and internal SOPs to maintain the highest standards of product quality
KEY RESPONSIBILITIES
- QMS & Document Control: Perform comprehensive reviews of QMS documents, including change controls, APQR, SOPs, OOS/OOT investigations, Deviations, CAPA, and Validation Master Plans.
- Audit & Compliance: Participate in surprise audits, self-audits of corporate functions, and assigned vendor audits as per the annual schedule.
- Contract Testing Laboratory (CTL) Management: Handle Quality Agreements, review site-specific test lists, schedule audits, and perform proactive yearly assessments of CTLs.
- Manufacturing Site Support: Coordinate LIMS-related activities and provide in office support for document reviews and investigations at Nerul, Daman, Vadodara,
and Baddi sites.
- Change Management: Review change assessments related to manufacturing sites and corporate functions, ensuring follow-up with Cross-Functional Teams (CFT) for action completion.
- Customer & Regulatory Interaction: Manage customer questionnaires, respond to regulatory queries, and handle the logging and investigation of customer complaints in TrackWise Digital (TWD).
- Project Implementation: Support the implementation of new digital projects, such as TrackWise Digital, and initiate Global CAPA assessments.
- Risk Management: Conduct risk-based qualification of Raw Material (RM) and Packaging Material (PM) vendors.
STAKEHOLDER INTERACTION
Type of Interaction: Internal
Interaction with: Cross-Functional Teams (CFT), Manufacturing Site Heads, Supply Chain, and Corporate Functions.
Nature of Interaction: Coordination for change assessments, follow-ups on action items, providing SOP
📌 Assistant Manager (Govandi East)
🏢 USV
📍 Govandi East