Senior Manager- Quality Assurance

Primary Job Function

• Lead and guide the team for LLM Operations and functionality on GMP aspects and Abbott policies and procedures.
• Monitor compliance of Loan license manufacturing sites and TPMs.
• Perform LLM site visits on scheduled basis and ensure compliance of LLM sites to cGMP, Abbott policies and Procedures.
• Ensure Pharmacopoeial compliance of Abbott products manufactured at LLMs.
• Review ongoing stability data and control samples of Abbott products.
• Ensure implementation of Abbott quality audit CAPA & closure at LLMs.
• Ensure timely investigation of the Market complaints within SLA, root cause analysis, CAPA implementation and effectiveness check.
• Coordinate with responsible CFT for NSQ's, Govt Agency responses.
• Review & assess change controls, deviations, OOS / Failures at LLM sites related to Abbott products.
• Ensure QTA compliance at LLMs and ensure QTAs are in place for all LL / TPMs.
• Monitor and support projects as assigned by the Manager.
• Ensure review and approve documents for tech transfer projects @ TPMs and FLQR review and approval for all projects for existing products and changes.
• Review of change controls and approval for products at TPMs in Abbott system.
• Tech Transfer at TPMs including Analytical method transfer, FLQR (First Lot Quality Review )
• Ensure and review GSR notifications and timely compliance at TPMs impacting Abbott products
• Ensure an effective communication process within cross functional team for execution of Quality projects supporting India Business.
• Ensure compliances related to regulatory changes impacting Abbott products and processes.
• Recruit, mentor, train and develop TPM QA India team members.
• Manage the CFT stakeholders including S& OP meetings, lead from the quality front.
• Ensure Deloitte Compliance across all LL sites including implementation of Abbott's processes and compliance across all LL sites in coordination with LL site management

Data Management

Stakeholder Management

Expectations & Skills

Team Management

Supervisory / Management Responsibilities

Direct Reports : - 02

Indirect Reports : - Contingent Workers @ LLMs ( Around 50 for SAP users management)

Position Accountability / Scope

Leadership / Team Leading

Minimum Education

Minimum Experience / Training Required

Languages

Skills Required

Data Management, Gmp, Due Diligence, Regulatory Compliance