Cipla USA · 3 weeks ago
IT-QA
Fall River, MA
Full-time
Onsite
Entry Level
$67K/yr - $95K/yr
2+ years expCipla USA is a leading global pharmaceutical company dedicated to high-quality medicines. They are seeking an IT-QA Associate to monitor electronic records and ensure compliance with quality standards in laboratory and manufacturing processes.
Pharmaceuticals
No H1B
Responsibilities
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
Qualification
Required
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
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
Preferred
Experience in MDI or DPI dosage form manufacturing
Benefits
Relocation may be a negotiable benefit
Company
Cipla USA
Cipla USA, the wholly owned subsidiary of Cipla (established in 1935), has been enabling patient access to affordable and high-quality medicines in the US for over 30 years.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Arunesh Verma
President & CEO, Cipla North America
Marc Falkin
Executive Vice President / Chief Commercial Officer
Company data provided by crunchbase