Sr. Associate, GxP IT Applications Administrator

Sun Pharmaceutical Industries Ltd•Billerica, MA

1d•$105,000 - $128,500•Onsite

About The Position

The Sr. Associate, GxP IT Applications Administrator will manage day-to-day Administration, user support and implementation of GxP Computerized Systems in QC Analytical Lab, Manufacturing and other regulatory functions including, but not limited to, networked and non-networked standalone instruments, firmware based instruments, HMI’s, SCADA systems and any GxP application software at any manufacturing site across the North America region.

Requirements

Minimum of a Bachelor's Degree, with preference being given to a candidate having a bachelor’s degree in Life Sciences, Pharmacy, Computer Science or Computer Information Systems (CIS) or related field.
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.

Nice To Haves

Requires travel for up to 25%-30% of the work hours.

Responsibilities

Collaborate with business partners and other stakeholders globally, regionally and locally, in various functions, instrument vendors, and other IT team members to implement, perform applications administration and support GxP applications and systems in a controlled laboratory, manufacturing and other regulatory functions.
Maintain GxP Systems Inventory
Manage end-to-end GxP IT Applications lifecycle management, validation documentation – deployment, support, maintenance, upgrade and retirement – in alignment with cGxP standards, regulatory guidance and company’s policies, standards and SOP’s
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, procedures and process automation pathways to streamline and increase effectiveness and efficiency of IT operations
Collaborate with various stakeholders globally and/or across the sites within the region to understand and implement best GxP IT practices
Support regulatory, customer and other such audits from IT department.
Other duties as assigned by IT Management
Travel between Sun sites required, as defined by business needs