Senior Manager- Quality Assurance

JOB DESCRIPTION :

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 NSQs 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 Abbotts 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 :

The base pay for this position is

N / A

In specific locations the pay range may vary from the range posted.

JOB FAMILY : Operations Quality

DIVISION :

EPD Established Pharma

LOCATION : India >

Mumbai : BKC Building

ADDITIONAL LOCATIONS :

WORK SHIFT :

Standard

TRAVEL : Not specified

MEDICAL SURVEILLANCE :

Not Applicable

SIGNIFICANT WORK ACTIVITIES :

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Required Experience :

Senior Manager

Key Skills

Continuous Integration,Quality Assurance,FDA Regulations,Root cause Analysis,TFS,Food Processing,ICH Q10,Jira,Software Testing,Quality Management,Selenium,Github

Employment Type : Full-Time

Experience : years

Vacancy : 1