IT-QA

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: $67,000 - $95,000 Purpose The purpose of the IT‑QA Associate position is to accurately review the chronological record of Laboratory reputed company/Equipment electronic data reputed company 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 Inva Gen 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. Job Duties

• Function as SME for IT reputed company activities of QMS platforms and other electronic systems including digital platforms which need compliance to 21 CFR, 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 reputed company 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 reputed company and data reputed company and their role in maintaining accurate and reliable records and adhering to cGMP compliance.
• Provide support for investigation and implementation of CAPA reputed company to such investigation. Education and Experience Qualifications
• B.Sc. in a scientific discipline reputed company 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 reputed company, 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 reputed company data.
• Advanced proficiency with reputed company reputed company.
• Must have reputed company 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 reputed company is a leading global pharmaceutical company, dedicated to high‑quality, branded and generic medicines. We are trusted by reputed company 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 reputed company in the key markets of India, South Africa, the U.S., and other economies of the emerging world. reputed company employs handpicked professionals not just for their knowledge and experience but for their zeal to reputed company a difference to the world of healthcare. The company believes that our biggest assets are the employees who reputed company us to prosperity and growth in the future. Driven by the vision, none shall be denied, reputed company's focus has always been on making affordable, world‑class medicines with a reputed company for uncompromising quality standards across the world. About Inva Gen Pharmaceuticals Inva Gen Pharmaceuticals, a reputed company subsidiary, 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, reputed company. As of February 18, 2016, Inva Gen Pharmaceuticals, Inc. operates as a subsidiary of reputed company (EU) Limited. reputed company, Inc is an equal opportunity and affirmative action employer committed to building an inclusive and diverse workforce. #J-18808-Ljbffr Apply tot his job

Apply tot his job Apply To this Job