Sr. Associate, GxP IT Applications Administrator

Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients.

As part of our mission to Reach People and Touch Lives, we deliver Innovative Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, we improve access to effective, affordable treatments that promote better health and well-being.

Reaching People. Touching Lives.

Job Summary:

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.

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’sUser 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

Education &

Qualifications:

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 preferred.

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.

Work Conditions:

Manufacturing/Production/Laboratory environment

Environmental related to manufacturing/production/laboratory environments:

Noise:
Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.

Fumes:
Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.

Odors:
Unpleasant smells.

Gases:
Examples include carbon monoxide and helium.

Dust:
Airborne particles of any kind, such as textile dust, wood, and…