Senior QA Analyst

IQVIA Analytics Services Private Limited (IN03); Bengaluru; On-site; INR 7,00,000 - 12,00,000; Full time

Job summary

A global clinical research firm in Bengaluru seeks a skilled professional to develop validation documentation for pharmaceutical equipment and computerized systems. The ideal candidate should have a Bachelor's degree in engineering or science and at least 3 years of experience in Computerized System Validation. Strong communication, technical writing skills, and ability to manage multiple projects are essential for this role.

Qualifications

• 3+ years of experience with Computerized System Validation.
• Experience with US FDA 21 CFR Part 11 and EU Annex 11.
• Ability to work on multiple projects simultaneously.

Responsibilities

• Develop validation documentation for pharmaceutical equipment.
• Create validation plans and standard operation procedures.

Skills

Computerized System Validation (CSV)

Quality Management Systems

Good communication skills

Technical writing skills

Project management

Education

Bachelor's degree in engineering / science

Tools

Trackwise

Master Control

ETQ

CEBOS

Job description

Bachelor's degree in engineering / science.
3+ years of experience/exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
Experience with the implementation of Quality Management systems (Trackwise/Master control/ETQ/CEBOS)

Responsibilities include:
Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
Creating project Deliverables which will encompass validation plans, specifications, test protocols and standard operation procedures

Requirements:
Good communication and technical writing skills are a must.
Able to work Independently.
Flexible to handle multiple projects parallelly.
Experience in Managing clients and Stakeholder.
Strong Manufacturing or Business process knowledge will be an added advantage.
Any Automation skill set/ability is an added advantage

We are IQVIA, a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.