Job Title: Pilot Plant IT Business Partner
FLSA Classification: Full-Time, Exempt Professional
Work Location: Fall River, MA
Work Hours: General Shift: 8:30 AM – 5:00 PM (may vary based on business needs)
Reports To: Site IT Manager
Salary Range: $65,000 - $105,000
Purpose:
This position is responsible for providing IT support & services like user support, hardware/software, network & infrastructure and handle all admin activities for QC lab.
Scope:
The scope (content and statements) of this job description is designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications. The intent is to give a general scope of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position and provide basic performance expectations. The scope of the job may be modified with respect to the department, group, and on an individual assigned basis to a sometimes-specific testing group. Consideration of education, relevant training, and experience or a combination of all three may also result in further modification of the role.
Duties and Responsibilities
User support include but are not limited to the following:
- User support including desktop/laptop, printer, and server & system administration.
- Handle surveillance system, attendance system and temperature scanner systems.
- Addressing domain and computer related issues in the user department.
- IT Administrator to all software and applications in the lab including Empower-3, lab solutions, Chromeleon, Tiamo, Syngistics, Thermo Nicolette etc.
- Activation & de-Activation of user accounts and profiles.
- Backup of data, archival & retrieval of data as per procedures.
- Periodically review software’s Audit Trail, maintain lab network, and address IT related issues promptly.
- Maintenance of servers for all software.
- Approach and deal with vendors as per the department requirements regarding the software and network issues.
- Computer Systems & Software’s Validation as per the requirements (e.g., IT SOPs for Quality control systems, IT validations, performing IQ/OQ/PQ, qualification etc.,)
- Any new IT initiatives implementation like serialization/aggregation etc.
- Provide support in extracting QC systems data, audit trails etc., during audits.
- Business Partnering for Application Support including SAP Support, SAP Roll Outs, Trackwise,
- Track & Trace, LIMS, SCADA and MFG/PKG/Quality systems.
- Handle WAN/LAN/VLAN, Office and Adobe products. Accessing data using NTFS, Ext Journal, Fat32 on different platforms.
- Performing IQ/OQ/PQ as per validation requirements.
- Support FDA and other audits from IT Admin perspective.
- Perform and support qualification of lab instruments and GXP systems as per Standard Operating Procedures.
- Develop validation plan, traceability matrix, Master Test Plan, Validation Summary Report documents.
- Develop Validation Deliverables that are required by SDLC policy and FDA regulations.
- Conduct assessments of regulated systems to assure validation procedures have been followed incompliance with company, divisional and departmental policies, and predicated rules.
- Involve in generation and implementation of QA and QC procedures and policies.
- Involve in Gap Analysis, Risk Analysis, and prepared Remediation plans.
- Conduct Periodic Evaluation to demonstrate that system remains in a validated state in its life cycle.
- Develop Validation Summary Report (VSR) to summarize all validation activities.
Education and Experience
- Bachelor’s degree or equivalent from an accredited college or university with major course work in computer science or related field is preferable.
- Minimum of 4-6 years of experience in a similar role.
- Must have strong knowledge and experience with PC hardware including performing installations, upgrades, and maintenance.
Technical Knowledge and Computer Systems Skills
- Have excellent organization, learning and teaching skills required to work in teams.
- Must have a strong coherent command of the English language, written and verbal as a first or second language.
- Proficiently communicate and understand (read and write) scientific / regulatory based‘work” in English.
- Must possess excellent presentation skills, strong documentation and technical writing skills, and able to apply relevant technical principles and practices.
- Must be able to communicate both technical and non-technical information clearly and concisely across all levels of the organization from executive leadership suite to employees working on the shop floor.
- Able to partner, facilitate, and collaborate with employees and managers across a diverse organization.
- Must be able to adapt to change and ambiguity.
- Must be proactive
- Must be able to work under general supervision with an orientation towards both tactical and strategic execution
- Knowledge of statistical packages is a plus.
Professional and Behavioral Competencies
- Able to prioritize, plan and work under tight schedules and deadlines.
- Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
- Must communicate clearly and concisely across levels, both orally and in written.
- Strong command over written and verbal English is required.
- Must be able to work under general supervision and able to work independently and in a team environment.
- Must be able to exercise appropriate professional judgment on matters of significance.
Work Schedule and Other Position Information
- Must be willing to work in a pharmaceutical setting.
- Must relocate to the Fall River, MA area
- Relocation negotiable.
- No remote work available.
- No employment sponsorship or work visas.
GLOBAL COMPANY
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.
Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.
CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)
About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.
EEO Statement
Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.
