Sr. Associate, GxP IT Applications Administrator

About the role

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.

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.

Education & Qualifications

• 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.

Work Conditions

• 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 silica.
• Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts.

Pay

The presently-anticipated base compensation pay range for this position is $105,000 to $128,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan.

Benefits

• Medical, dental and vision coverage
• Life insurance
• Disability insurance
• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Paid time off benefits (vacation time and sick time)

Schedule

Requires travel for up to 25%-30% of the work hours. Travel between Sun sites required, as defined by business needs.