Clinical QA Auditor
Orbit pharmaceuticals · Vadodara · onsite · Posted 44d ago
About a minute. You'll make an account on the way through.
About this role
Job Description
Position Title- Clinical QA Auditor
Department- Quality Assurance
Experience Requirement: 2-3 years of experience in Clinical Quality Assurance.
Qualification Requirement: B.Pharm., M.Pharm., M.Sc., or an equivalent qualification in a relevant scientific discipline.
Profile Requirements:
1. Should be well-versed in Quality Management System (QMS) requirements applicable for Clinical studies.
2.Should have sufficient expertise in preparation and review of SOPs and other QMS related documents.
3.Plan and Conduct Internal audits (System audit) and Vendor audits (External audit).
4.Proficiency in Review of Clinical Study Protocols, Informed Consent Forms (ICFs), Case Record Forms (CRFs) and other protocol related documents.
5.Plan and conduct In-process audit of study related activities like, ICF presentation, Check-in activities, dose administration, sample collection and processing, safety monitoring, pharmacy related activities etc.
6.Plan and conduct retrospective audits of study related raw data like informed consent forms, screening documents, case record forms, trial master file, investigational product related documents, sample separation data, CSR etc.
7.Proficiency in Review of Calibration and Qualification/Validation documents of the instruments/equipments.
8.Conduct SOP and QMS-related training programs as per the approved training schedule.
9.Manage the issuance, control, distribution, and maintenance of SOPs, study-related documents, and other QMS documents.
10.Archival and retrieval of QA documents.
11.Compliance verification of QA observations and their timely closure.
12.Review and tracking of Change Control, Deviation and CAPA.
13.Good understanding of ICH-GCP, CDSCO regulations, and applicable regulatory guidelines.
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Skills
About Orbit Pharmaceuticals
Orbit pharmaceuticals
11-50
employees
Ahmedabad
IN
₹4.1L PA avg
Avg at Orbit Pharmaceuticals
About
Orbit Pharmaceuticals is one of the leading manufacturers and exporters of high quality pharmaceutical products, located in Ahmedabad, India.
We are dealing with manufacturing of different dosage forms such as Capsules, Semi solids, Oral liquids and Injectables, with high standard quality and competitive price.
Apart from the above activity, we are engaged in distribution of products including branded, generics, ethical and over the counter solutions (OTCs) from the UK, Europe and Asian origin as well as CE marked medical devices and surgical products to local retail pharmacies and hospitals with our operating division Nami Pharmaceuticals situated in Middlesex, London, licensed by the MHRA with WDA (H).
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