QA Analyst – eTMF / GxP / 21 CFR Part 11 Suzva Software Technologies

6.0 - 10.0 years

5 - 9 Lacs

chennai

Work from Office

Job Overview We are seeking experienced QA Analysts with expertise in eTMF system implementation, GxP compliance, 21 CFR Part 11, and ICH-GCP. The role involves validation, compliance testing, documentation review, and supporting regulatory requirements across clinical and quality systems.This is a Chennai-based onsite role, suitable for candidates with strong experience in regulated environments. Key Responsibilities Lead and participate in eTMF system implementation and validation activities Ensure systems comply with GxP, 21 CFR Part 11, ICH-GCP, and audit requirements Perform validation, functional testing, and compliance reviews for clinical applications Review SOPs, validation delivera...

Posted 2 hours ago

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Executive - Quality Control Jubilant Ingrevia Limited

8.0 - 12.0 years

0 Lacs

bharuch, gujarat

On-site

As an Assistant Manager - Quality Control at Bharuch SEZ, you will play a crucial role in ensuring compliance with global regulatory requirements such as 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, and HACCP. Your responsibilities will involve regularizing QC activities as per cGMP requirements, ensuring lab compliance with regulatory and Pharmacopeia requirements, reviewing hybrid and electronic data for IPQC & FG analysis, conducting analytical method validation, OOS & OOT, and demonstrating knowledge of IMS system standards. Key Responsibilities: - Regularize the QC activities as per cGMP requirements. - Ensure compliance with regulatory and Pharmacopeia requirements for lab. - R...

Posted 2 months ago

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Project Manager Instem

0.0 years

0 Lacs

pune, maharashtra, india

On-site

Location: Hybrid, Pune-Twice a week in the office Status: Permanent, Full Time Package: Competitive Salary (fixed), 5 Day Working Week, Flexible Working(with one-off allowance), Development & Opportunity (Personal & Technical), Group Medical Policy, Group OPD Cover, Personal Accident Cover, Term Life Cover, 26 Days Leave + 9 Public Holidays + Buy & Sell Scheme, Referral Scheme. Why are we hiring a Project Manager We are hiring this position due to retirement within the team. The Project Manager is a highly valued role where collaboration and a superior team player mindset is non-negotiable. As a Project Manager (PM) your mission is to be the primary liaison for our customers and to provide l...

Posted 2 months ago

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