Quality Analyst by ClinAsia Labs Private Limited

Job Description

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* Good technical knowledge on QAU processes.
 
* Sound awareness of all relevant regulations, including ICH GCP, CDISC, ISO 9001:2008 and applicable Guidelines

* Good experience in the preparation of Clinical Domain SOPs



* Able to perform QA reviews of Protocols, CRFs, Clinical Study  Reports, Monitoring Visit Reports, Mock (TLFs), CDISC-data conversions and other study related documents

* Good experience in Change control & Deviation control process

* Responsible for handling internal audits and implementing CAPA process

* Able to conducting cGCP & applicable Trainings periodically for all employees.

Salary: As per Industry Standards

Industry: Pharma / Biotech / Clinical Research

Functional Area: IT Software - QA & Testing

Role Category: QA/Testing/Documentation

Role: Quality Assurance/Quality Control Executive

Keyskills: Quality analyst, CRO quality analyst

Desired Candidate Profile

Education: (UG - Any Graduate - Any Specialization, B.Tech/B.E. - Any Specialization, B.Sc - Any Specialization) AND (PG - Any Postgraduate - Any Specialization, MBA/PGDM - Any Specialization, MCA - Computers, M.Sc - Any Specialization) AND ( Doctorate - Doctorate Not Required)

Please refer to the Job description above

Company Profile

ClinAsia Labs Private Limited
http://www.maxisit.com/index.php & http://www.clinasia.com/

ClinAsia(Formerly Known as Maxis Software Therapeutics Pvt.Ltd) is the closely-held affiliation of MaxisIT Inc. (NJ, USA organization). MaxisIT has been in business for over 10 years serving primarily to Pharmaceutical and Life Sciences industry companies in the areas of clinical trial management, clinical data management, biostatistics, regulatory documents and submission management and Pharmacovigilance utilizing its organically grown integrated suite of software CTRenaissance®.

Contact Details

Recruiter Name:HR Department

Contact Company:ClinAsia Labs Private Limited

Address: Plot No: 13, Telecom Nagar Near to Maulana Azad National Urdu University Gachibowli, Hyderabad HYDERABAD,Andhra Pradesh,India

Email Address:

Telephone:040-67234619

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Posted in: B.Pharmacy,B.Tech,Hyderabad,M.Sc,Quality,Quality Assurance