IT-QA Associate

Job Title:                                  IT-QA Associate

FLSA Classification:               Full-Time, Exempt Professional 

Work Location:                        Fall River, MA

Work Hours:                            General: 8:00AM – 5:00PM (May vary based on business needs)

Reports To:                              Site Quality Assurance Head

Salary Range:                          $65,000 – $90,000

PURPOSE

The purpose of the IT - QA Associate position is to accurately review the chronological record of Laboratory Instrument/Equipment electronic data related activities that provides documented evidence of relevant details of specific events.   

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 of this job description is to be representative of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position satisfactorily and in accordance with the established performance expectations. The scope of the job may be modified with respect to the department, group, and on an individual assigned basis. Consideration of education, relevant training, and experience or a combination of all three may also result in further modification of the role as decided by the Head of the Quality function in consultation with the HR dept.

JOB DESCRIPTION

The IT- QA Associate position is an individual contributor role and a member of the InvaGen Pharmaceuticals Quality Team. The position monitors changes to electronic records, alterations in critical parameters or any other actions that could impact product quality.  This position reports to the Site Quality Head.

The job duties for this position include but are not limited to the following:

• Function as SME for IT related activities of QMS platforms and other electronic systems including digital platforms which need compliance to 21CFR, Part 11 requirements.
• Conduct regular audits of the audit trail to identify any irregularities or potential issues. Additionally, routinely review and analyze the data to proactively address any emerging trends or areas for improvement.
• Provide comprehensive training to employees involved in the analytical laboratory related activities as well as manufacturing process who are entitled to use digital platforms for execution of GMP/GLP activities. Ensure that users understand the importance of audit trail integrity and data integrity and their role in maintaining accurate and reliable records and adhering to cGMP compliance.
• Provide support for investigation and implementation of CAPA related to such investigation.

EDUCATION AND EXPERIENCE QUALIFICATIONS

• B.Sc. in a scientific discipline related to the pharmaceutical industry (Biology, Chemistry, Pharmacology, Biochemistry, etc).
• Basic knowledge and Industry experience of Quality System relevant to electronic records storage, retrieval, archival and audit of electronic data is must.
• Minimum of two (2) years’ experience in a quality assurance in a GMP environment specific Quality Control Laboratory and Manufacturing operations in a pharmaceutical manufacturing organization.
• Experience in MDI or DPI dosage form manufacturing preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

• Candidates must have an aptitude for quantitative problem-solving or advanced analytics.
• Ability to multitask efficiently, prioritize quickly, and manage time effectively.
• Candidates must have experience in writing and executing performance tests.
• Database and computer skills; talent for analyzing and visualizing complex data.
• Advanced proficiency with Microsoft Excel.
• Must have current Good Manufacturing Practices (cGMP) knowledge.
• 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 prioritize tasks with strict deadlines.

OTHER JOB INFORMATION

• Relocation may be a negotiable benefit
• No remote work available.
• No employment sponsorship.

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.

Cipla, Inc is an equal opportunity and affirmative action employer committed to building an inclusive and diverse workforce.