Job Title: QA Associate -IT

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: $76000 $103000

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.

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

• . 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 Indias 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 Ciplas 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.