Administrator, IT, New Brunswick, NJ - Onsite

Sun Pharmaceutical Industries • New Brunswick, NJ

32d • Onsite

About The Position

Sun Pharmaceuticals Industries Inc. is the fourth largest generic pharmaceutical company in the world, and rapidly building our brand presence. We manufacture, market and distribute pharmaceuticals to the nation's largest wholesalers, distributors, warehousing and non-warehousing chain drugstores as well as managed care providers. Our goal is to continue to develop and market quality products that bring value to our customers and ultimately the patient. Current manufacturing capabilities allow Sun Pharma to develop products across most therapeutic categories.

At Sun Pharma we believe our people are an invaluable asset. Our culturally diverse workforce is one of our biggest strengths, along with the rich experience they bring across varied skill-sets. We are proud that our global workforce is bound by our common values.

Job Summary:
Manage day-to-day System Administration of Computerized GxP Instruments and Machines in Analytical Lab and Manufacturing Operations 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. Preference will be 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.
• Requires travel up to 25%-30%
• Minimum 7-8 years of hands on experience maintaining GxP systems, applications, instruments and shop floor machines in a manufacturing environment with detail orientation and strong problem solving, analytical, and critical thinking skills.

Responsibilities

• Apply cGMP principles by following internal standard operating procedures (SOPs), work instructions (WIs), and regulatory requirements.
• Collaborate with QC analysts and managers, instrument vendors, and IT team members to implement and support GxP systems in a controlled laboratory and manufacturing environment.
• Provide support during new systems implementation, overseeing design, development, or configuration to ensure the solutions will meet business needs while adhering to IT policies and procedures, compliance standards, and GxP requirements.
• Participate in GMP validation activities including the execution of IQ/OQ/PQ testing; assist with creation of test scripts as required. Perform integration and system level tests and execute any necessary supporting documentation.
• Under general guidance assists with the procurement, installation, repair, preventative maintenance, calibration, and troubleshooting of equipment including qualification activities (IQ/OQ/PQ).
• Conduct Periodic Reviews to confirm computerized systems are compliant with company procedures and regulatory agency requirements.
• Execute activities in support of day-to-day operations at various sites across the North America region, with responsibility for GMP and non-GMP processing activities. This includes, but not limited to, User Access Management - activation of new users, deactivation of users and review of access privileges, Backup of all GxP systems is being taken as per schedule, Recovery of GxP systems when required and any other activity assigned by IT Management.
• Assist with change control impact assessments for GxP systems changes, perform Root Cause Analysis and CAPA.
• Propose alternate processes and procedures 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 practices

Benefits

• Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program.
• Employees also receive various paid time off benefits, including vacation time and sick time.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level