QA Associate - IT Support (MA)

Job Title: QA Associate – IT Support

Location: Fall River, MA

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.

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.

In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla’s respiratory business in the United States.

Job Purpose:

The purpose of the QA Associate Inspector position is to monitor and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs).

Duties and Responsibilities:

The Quality Assurance (QA) Associate – IT Support position is an individual contributor role and a member of the InvaGen Pharmaceuticals Quality Team. The position reports to the Site Quality Lead. The essential and typically expected job duties for this position include but are not limited to the following:

• Working directly with IT for the implementation of new computerized systems to ensure compliance with 21CFR Part 11
• Creation of new SOPs, as needed, to describe the processes associated with new computerized systems
• Review and approval of all computer system validation deliverables for quality computerized systems
• Routine review of audit trails and 21 CFR Part 11 compliance for established computer systems
• Working with inspectors and auditors to demonstrate compliance and full understanding of 21 CFR Part 11
• Working with cross functional teams, such as Cipla India IT and InvaGen IT, for troubleshooting of computerized systems.
• Creation of training material and hands on training for any new/revised computer systems
• Coordination for commissioning of instrument upgrades with IT and engineering, as needed
• Other duties as requested by Site Quality Lead

Education and Experience:

• Minimum high school diploma.
• Advanced training or education in pharmaceutical quality compliance or related field of study from an accredited college/university is preferred.
• Minimum of five (5) years’ experience in an IT role within a GMP pharmaceutical work environment.
• Proficient use and management of computer hardware and software applications such as Microsoft Office tools, SAP, TrackWise, Master Control, and other business applications.

Physical requirements

• Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.

Professional and Behavioral Competencies:

• Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Proficiency in the English language to include usage, spelling, grammar, and punctuation.
• Must have strong attention-to-detail.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and communication skills (written, verbal, and presentation).
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.
• Preferred to have current Good Manufacturing Practices (cGMP) knowledge.
• No employment sponsorship or work visas.

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.