4 Oot Investigations Jobs

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8.0 - 12.0 years

0 Lacs

hyderabad, telangana, india

On-site

QA Head (OSD) Experience: 8-12+ years Qualification: B.Pharm / M.Pharm / MSc Location: Patancheru, Hyderabad, India Salary: 812 LPA Please send your resume/cover letter to [HIDDEN TEXT] Responsibilities Lead regulatory inspections including WHO-GMP, CDSCO, EU-GMP, PIC/S, MHRA, USFDA, and customer audits. Ensure full site readiness and drive timely closure of audit CAPA. Oversee implementation and monitoring of the Quality Management System. Review and approve deviations, CAPA, OOS, OOT, change controls, and market complaints. Supervise APQR/PQR preparation, review, and approval. Review and approve Master BMR/BPR, MFR, SOPs, validation protocols, and reports. Direct batch release processes, l...

Posted 3 weeks ago

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2.0 - 5.0 years

3 - 5 Lacs

ahmedabad

Work from Office

Perform analysis of raw materials, in-process samples, and finished products as per SOPs Conduct chemical, instrumental, and microbiological tests using HPLC, GC, UV, IR, Dissolution, KF, pH Meter, etc Ensure documentation compliance as per cGMP, GDP, and regulatory guidelines Prepare and maintain test records, COAs, logbooks, and stability data Perform calibration and routine maintenance of laboratory instruments Monitor laboratory environmental conditions and maintain cleanliness Support OOS/OOT investigations, deviations, and CAPA activities Ensure compliance with ALCOA+ principles during documentation Follow safe handling procedures for chemicals and lab equipment Coordinate with QA, Pro...

Posted 1 month ago

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2.0 - 6.0 years

0 Lacs

pithampur, madhya pradesh

On-site

As a QC Chemist/Analyst, your role involves performing a variety of tasks related to quality control and analysis. Your key responsibilities will include: - Sampling of raw materials, packaging materials, intermediates, and finished products as per Standard Operating Procedures (SOPs). - Conducting chemical, physical, and instrumental analysis using methods such as UV, IR, and KF as per pharmacopeia or in-house validated methods. - Analyzing water, stability, and environmental monitoring samples. - Maintaining Good Laboratory Practices (GLP) and ensuring compliance with cGMP guidelines. - Preparing, reviewing, and maintaining accurate test records, logbooks, Certificate of Analysis (COAs), a...

Posted 2 months ago

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5.0 - 10.0 years

0 Lacs

amritsar, punjab

On-site

As a QA Manager at Systacare, a trusted name in the pharmaceutical industry, your primary responsibility will be to ensure adherence to regulatory requirements and maintain the highest standards of compliance in injectable manufacturing. With a strong focus on innovation, compliance, and patient safety, Systacare is expanding its team and is seeking passionate professionals to join the organization. You will lead and manage the QA team to ensure compliance with cGMP, regulatory standards, and company SOPs. Your role will involve overseeing quality systems, including deviation management, change control, CAPA, OOS, and OOT investigations. It will be crucial for you to ensure quality assurance...

Posted 3 months ago

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