Clinical Quality Assurance

2 days ago

Mumbai, India Alpha MD Pvt Ltd Full time

**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 2 - 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, self-motivated; 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**: ₹500,000.00 - ₹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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