Research & Quality Systems IT Admin Specialist

Brief team/department description:

Our Digital team at Azurity is building new capabilities utilizing cutting-edge Research Quality IT Systems. We are looking for a dynamic, change inspired, Individual self-driven hands on Team Member.

Principle Responsibilities:

• Serve as the IT business partner in support of Azurity s research development and Quality functions.
• Hands on Troubleshooting Support enterprise Quality Control and Quality Assurance applications (QMS, Document Management, LIMS, ELN, etc.).
• Support current and future research development and quality needs in line with organization.
• Provide support and applications management for standalone laboratory instruments in support of both our Development and QC Laboratories.
• Guide and support computer systems compliance activities including change control and Computer Systems Validation (CSV).
• Align processes and systems capabilities, identify the gaps and come with industry best practices.

Required Educations, Skills, and Experience:

• Bachelor s degree in computer science engineer or pharma IT engineer, with preference relating to Pharma LMS QC Lab IT/ systems, chemistry LMS QC Lab IT/ systems, quality management IT systems or similar fields of study.
• At least three (3 to 7) years of relevant hands-on experience in the pharmaceuticals or life science industry, to include systems support of Research Development and Quality organizations with hands-on laboratory instrumentation experience.
• Working knowledge of GLP and GDP, including Computer Systems Validation (Part 11, Data Integrity, Predicate Rule).
• Prior hands-on experience with at least one -two of the following: LIMS implementation, QMS implementation, calibration management implementation, or ELN implementation.
• Especially Track Wise DMS and QMS, Cornerstone, QC systems ( OpenLab, Titrator, EMS, Trinty, UV SPEC)
• Demonstrated business communications, influencing, and situational awareness skills.
• Innovative and proactive mindset. Ability to translate complex business problems into solutions.
• Flexibility to wear several hats, for troubleshooting high Low priority tasks related to DMS and QMS, Cornerstone, QC systems ( OpenLab, Titrator, EMS, Trinty, UV SPEC)
• Business process design and documentation skills.
• Excellent written and verbal English communication skills
• Ability to work onsite during flexible hours to support India, US and EU operations

Preferred Skills and Experience:

• Direct experience with the following platforms: Agilent, Empower, and TrackWise QMS.
• Direct hands-on experience with standalone laboratory instrumentation systems (i.e., Mass Spec, FTIR, Plate Readers, etc.)
• Hands-on software development or systems implementation experience.