Billerica Sr_ Associate, GxP IT Applications Administrator MA

 

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’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

 

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.
• 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 silica.

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

 

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. 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.