Title:  Senior Associate, IT Systems Administrator

Job Summary

Manage day-to-day System Administration, user support and implementation of GxP Computerized Systems in QC Analytical Lab Manufacturing and other regulatory 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.

Area Of Responsibility

• Collaborate with business partners 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. This includes, but not limited to maintaining GxP Systems Inventory, User Access Management – activation, modification and deactivation of users, managing user access privileges, implementation and/or retirement of GxP systems, ensuring that Backup of all GxP systems is being taken, Recovery of GxP systems when required and any other related activity assigned by IT Management through application of cGMP principles and following internal standard operating procedures (SOPs), work instructions (WIs), and regulatory requirements.
• Provide support during new systems implementation, overseeing design or configuration and validation (IQ / OQ/ PQ) to ensure the solutions will meet business needs while adhering to IT policies and procedures, compliance standards, and GxP requirements.
• Conduct Periodic Reviews such as but not limited to User Access Management, Systems Validation Reviews, SOP Reviews etc. to confirm computerized systems are compliant with company procedures and regulatory agency guidelines and requirements.
• 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.

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

Physical Requirements:

• Able to lift and carry up to 50 lbs.
• While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle objects, or feel objects, tools, or controls; and reach with hands and arms.
• The employee is occasionally required to stand, stoop, kneel and crouch.
• Specific vision abilities required of this job include close vision, distance vision, color vision and the ability to adjust focus.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Travel Estimate

Up to 25% to other sites within North American geography and sometimes for vendor audits

Education and Job Qualification

• 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 for upto 25%-30% of the work hours.

Experience

• Minimum 6-7+ years of hands on experience maintaining, administering GxP systems, applications, instruments and shop floor machines in a manufacturing and/or quality function with detail orientation and strong problem solving, analytical, and critical thinking skills.

The presently-anticipated base compensation pay range for this position is $98,000 to $119,500. 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. 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.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.