Research & Quality Systems IT Admin Specialist

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

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.

Physical & Mental Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to sit for long periods of time
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
• May occasionally climb stairs and/or ride elevators
• The employee must occasionally lift and/or move up to 25 pounds
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
• Other miscellaneous job duties as required