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 nations 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, HMIs, SCADA systems and any GxP application software at any manufacturing site across the North America region.
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
Education/ Qualifications:
Minimum of a Bachelor's Degree. Preference will be given to a candidate having a bachelors 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.
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.
The presently-anticipated base compensation pay range for this position is $107,500 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.
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.
