Clinical Quality Assurance - Mumbai, India - Alpha MD Pvt Ltd
5 days ago
Description
JD of Quality Assurance
General Information
Designation:
Quality Assurance
Status:
Full-time
- In depth knowledge regarding Clinical trial processes, drug discovery life cycle, and computer systems used in clinical Sciences.
- Ability to understand life sciences and healthcare regulatory reporting and compliance.
- Experience in working on documentation of system development, System testing and validation life cycle.
- Well versed in quality control of clinical trial processes (trial startup, trial conduct, trial close out), site documentation, data management workflows.
- Proficient to develop Standard Operating procedures for product development, IT processes.
- Ability to independently handle all audits and inspections carried by Sponsor / regulatory agencies.
- Excellent oral and written communication skills.
Experience:
Min - 5 years' experience.
Qualification:
- B.Sc/M.Sc (IT)/ computer science, Diploma / Degree in Clinical research.
- Excellent verbal and written skills (English).
- Good organizational, interpersonal, and team skills.
- Ability to deliver results under pressure.
- Goal oriented, selfmotivated; able to work independently but within a team environment
Desired Skills/Experience:
- Identify validation requirements country/ region wise and map product functionality and compliance.
- Define validation strategy, develop validation test scripts, validation protocol, validation report.
- Proactive in documentation system validation process and meeting project deliverables.
Industry:
Pharma/ Biotech/ Clinical Research
Functional Area:
Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Salary:
₹500, ₹800,000.00 per year
Schedule:
- Monday to Friday
Application Question(s):
- What is your current CTC?
- What is your expected CTC?
- What is your notice period?
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