Laboratory Systems Analyst

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:

• To provide production and project support for laboratory computer systems, including system administration activities related to user account management, desktop support, instrumentation computer builds, hardware and software troubleshooting, technical support, and validation/qualification for new and existing systems. 
• This position will be responsible for providing Information Technology support for the following areas: QA, QC, 

• Support Laboratory data collection and support applications.
• Primary support for Waters Empower 3 application.
• Support other lab systems including Malvern Particle Sizers, ICALIS-IDIS, OMNIC FTIR, Bruker XRD, ICP-Mass Spec, Imaging Software, UV/VIS Spectroscopy, Labware LIMS, Proveris Sprayview, LabX, PharmSpec HIAC, Vitek 2, Citrix, and others
• Support and maintain Laboratory application servers, PC workstations.
• Engage and work with support vendors to resolve issues in a timely manner with an understanding of the root cause.
• Ensures lab systems daily back-ups are running.
• Maintain lab file shares.
• SOP Review and Development.
• Work with all areas to develop process and technology-based solutions for their business needs.
• Active participation in all systems implementations and technical development.
• Manage the compliance level of all systems in accordance with corporate and regulatory standards.
• Collaborate with other IT areas to address overall systems integrity, compliance, system integration and develop corporate IT/strategy.

Manage user requirements 

• Technical support for new implementations and upgrades.
• Oversee Installation Qualifications (IQs), Operational Qualification (OQs), Performance Qualifications (PQs), 21 CFR part 11 testing, and acceptance testing as required
• Interact with the business to understand business requirements at a functional / procedural level and translating these into technical design.
• Generate specifications for configuration / development and implementation.
• Document, train, and assist in system documentation.
• Manage the full software development lifecycle (SDLC), including associated change management and validation processes.
• Project Management skills for new implementations and upgrades.

Provide ad hoc reports to satisfy client information requests

• Computer systems validation
• Validate new systems or changes to existing systems, including the preparation and execution of qualification protocols.
• Prepare necessary documents, e.g. user requirements, requirements traceability matrix.
• Prepare / update systems governance, i.e. Standard Operating Procedures.
• Perform necessary IT change controls for various systems.

Data integrity and archiving

Requirements:

• BS degree or equivalent work experience.
• Minimum of 5 to 8 years of relevant experience.
• Pharmaceutical/Life Science experience beneficial.
• Strong knowledge of Waters Empower 3 application.
• Experience with common laboratory equipment and software.
• Experience with GAMP, CSV, CFR 21 Part 11.
• Database (SQL Server/Oracle) experience a plus.
• Trackwise Digital experience a plus.

Avamar Backup experience a plus

Skills & Abilities:

• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.