Senior GxP IT Applications Specialist

Sun Pharmaceutical Industries, Inc.; Billerica, Northern (MA, KY); Hybrid; USD 105,000 - 129,000; Full time

Benefits offered by this job

Annual bonus plan

Medical/dental/vision coverage

401(k) savings plan

Job summary

Sun Pharmaceutical Industries, Inc (USA) seeks a Sr. Associate, GxP IT Applications Administrator to manage day-to-day administration and validation of GxP computer systems in QC Analytical Lab, Manufacturing and regulatory functions across North America.

The role requires collaboration with global partners, end-to-end lifecycle management, access control, backup/recovery, change control, audits and up to 25–30% travel, supporting a broad regulated IT footprint.

Qualifications

• Excellent understanding of GAMP 5, 21 CFR Part 11, Computer System Validation and Quality Management System.
• Excellent collaboration and communication skills.
• Ability to manage competing priorities and flexibility to shift workload when needed.
• Excellent written and verbal communication skills and working knowledge of Microsoft Office Applications.
• A team player with ability to work with people at all levels and diverse skill sets.
• Requires travel for up to 25%-30% of the work hours.

Responsibilities

• Collaborate with business partners and other stakeholders globally to implement, perform applications administration and support GxP applications.
• Manage end-to-end GxP IT Applications lifecycle management – deployment, support, maintenance, upgrade and retirement.
• User Access Management lifecycle – activation, modification, deactivation and periodic access reviews.
• Ensure that Backup of all GxP systems is being taken.
• Recovery of GxP systems when required.
• Assist with QMS processes within IT, especially change control impact assessments, CAPA execution and managing deviations and incidents through root cause analysis for GxP systems changes.
• Propose alternate processes and automation pathways to streamline IT operations.
• Collaborate with stakeholders globally to implement best GxP IT practices.
• Support regulatory audits from IT.
• Travel between Sun sites as needed.

Skills

GxP IT knowledge

Communication skills

Project management

Team collaboration

Travel readiness

Problem solving

Education

Bachelor's Degree in Life Sciences/Pharmacy/CS/CIS or related

Job description

Sun Pharmaceutical Industries, Inc (USA) seeks a Sr. Associate, GxP IT Applications Administrator to manage day-to-day administration and validation of GxP computer systems in QC Analytical Lab, Manufacturing and regulatory functions across North America.

The role requires collaboration with global partners, end-to-end lifecycle management, access control, backup/recovery, change control, audits and up to 25–30% travel, supporting a broad regulated IT footprint.