Senior Specialist - LIMS Administration

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.

Responsibilities:

• Prepares crystal reports.
• Creates or approves static data entries.
• Adds/modifies calculations, workflows, and schemas as necessary.
• Codes LIMS system to customize software platform.
• Integrates and customizes software with laboratory instrumentation
• Responsible for instrument integration.
• Builds Crystal Reports.
• Builds/Configure Electronic Laboratory Notebooks.
• Participate in cross-site implementation of new LIMS features and enhancements
• Coordinates roll-out of additional LIMS phases..
• Assists in Project Planning and Budget Spending.
• Performs periodic audits on the system, collates and presents the results of the audit to senior management.
• Develop training modules and provide user training as necessary.
• Interact with laboratory personnel to ensure necessary developments are present and functioning, as necessary.
• Interface with IT department on global LIMS issues.
• Follows EH&S procedures to ensure a safe work environment.
• Performs other LIMS-related responsibilities as required by management.

Requirements:

• Bachelor’s degree in life science, physical science, or technology field with 5+ years’ laboratory experience performing development functions for a GMP laboratory
• 3+ years’ experience within software development
• Worked within a regulated environment (Pharmaceuticals, Medical Devices, Biotech or other regulated field)

Knowledge:

• Knowledge of 21 CFR Part 11
• Strong knowledge of Computer System Validation techniques and practices
• Company SOPs applicable to job
• Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow
• Strong understanding of Company SOPs applicable to job
• GMP Knowledge of FDA regulations, primarily GMP regulations
• Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow
• In-depth knowledge of Crystal Reports, SQL programming, and SSL scripts or other varying scripting languages such as JavaScript, SQL, Java

Skills & Abilities:

• Advanced computer skills
• Strong attention to detail. Highly productive, able to manage time and prioritize tasks to meet timelines
• Strong interpersonal and communication skills; confident presenter, clear, concise technical writer. Able to interact with various departments and levels
• Customer focused
• Troubleshooting and critical thinking skills. Able to define problems, collect data, establish facts and draw conclusions