IT Quality Assurance Specialist

4 days ago


Fall River, Massachusetts, United States Cipla Full time
Job Title: IT Quality Assurance Specialist

The IT Quality Assurance Specialist will play a crucial role in ensuring the accuracy and integrity of electronic records and data in our laboratory and manufacturing operations. This position will be responsible for monitoring changes to electronic records, identifying potential issues, and providing comprehensive training to employees on the use of digital platforms for GMP/GLP activities.

Key Responsibilities:
  • Function as a Subject Matter Expert (SME) for IT-related activities of QMS platforms and other electronic systems, ensuring compliance with 21CFR, Part 11 requirements.
  • Conduct regular audits of the audit trail to identify irregularities or potential issues and proactively address emerging trends or areas for improvement.
  • Provide comprehensive training to employees on the use of digital platforms for GMP/GLP activities, ensuring they understand the importance of audit trail integrity and data integrity.
  • Support investigation and implementation of Corrective Action Preventive Action (CAPA) related to electronic data integrity.
Requirements:
  • Bachelor's degree 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.
  • Minimum of two (2) years' experience in a quality assurance role in a GMP environment, specifically in a Quality Control Laboratory and Manufacturing operations in a pharmaceutical manufacturing organization.
About Cipla:

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. Our focus is on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.



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