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Associate Director - QC Systems LES BAU Operations - GCC

Associate Director - QC Systems LES BAU Operations - GCC

GSK India

10 - 15 years

40 - 45 Lacs

bengaluru

Posted:3 days ago| Platform:

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Skills Required

procurement qc team management data management analytical oncology gmp associate director troubleshooting analytics

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Purpose

The Associate Director QC Systems BAU Operations GCC supports the day to day business as usual maintenance operations of QC systems such as LES. The role manages the QC Systems LES BAU Operations team and also interacts with the wider QC System LES BAU team, site QC lab stakeholders and the Tech organization to ensure successful maintenance and use of QC systems.

The role acts as a key interface between the site QC organization and the TECH organization/software provider

Key Responsibilities

Leadership Team Management:

Ensure that global processes, business rules and standards are followed for QC Systems BAU operations that are supported by the global QC Systems LES BAU Operations team.
Focus on BAU end to end request management and Help Desk support operations, ensuring Operational Level Agreement (OLA) and Service Level Agreement (SLA) delivery timeframes are met at least 90% of the time.
Use laboratory and system expertise and skills to identify ways to continuously improve the effectiveness and efficiency of QC Systems BAU operations to improve the user experience and improve Quality performance.
Ensure that compliance to data standards is maintained in order to ensure that all data configured and entered in the system is fit for all business uses.
Proactively utilize data integrity requirements, regulatory standards, identified risks and data analytics tools and processes to manage control of laboratory data lifecycle, ensuring systems are configured and utilized to complimentarily meet regulatory requirements and productivity expectations to meet current and future needs of the QC organization.
Ensure risks and deviations are raised in a timely manner and act upon outcomes to identify and deliver improvements and resolve potential or actual issues. Ensure successful preparation and follow-up of inspections on QC Systems related topics. Responsible for the following periodic business activities: System audit trail review, Annual user review
Engage with and mentor QC systems BAU operations network to ensure effective knowledge transfer and sufficient level of capability is maintained within the QC Systems BAU operations team.

Knowledge/ Education / Experience Required

Bachelors degree with minimum of eighteen plus (16+) years of experience in pharmaceutical industry in a highly regulated environment
Minimum 10 years of experience working in / with a GMP Laboratory
Experience in GMP laboratory testing activities
Experience in implementation and management of IT and automated equipment.
Experience in Data management, Data Governance and reporting / analytics.
Ability to analyze complex data/information/scenarios and make rational, risk-based decisions which are communicated and/or escalated clearly and confidently, e.g. troubleshooting, root cause analysis, impact assessment, proposing relevant CAPAs.
Good working knowledge of analytical equipment, techniques and laboratory operations
Experience in managing laboratory systems data maintenance operations
Demonstrated ability to innovate
Proven success in leading transformational change
Skilled in influencing at more junior and more senior levels in the organization
open mind and flexible approach of situation resolution and problem solving, multidisciplinary rationales, communication capacity.
Ability to travel and work independently
English speaker

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Associate Director - QC Systems LES BAU Operations - GCC