QA Validation Professional
This position plays a critical role in ensuring that equipment, computerized systems, facilities, and utilities meet regulatory standards.
* Reviews and approves qualification and requalification protocols for equipment, systems, facilities, and plant utilities.
* Supports execution of qualification activities, including area and drawing walkdowns and vendor interactions.
* Reviews and approves related documents, including User Requirement Specifications, SOPs, drawings, and support files.
The ideal candidate will have a strong understanding of regulations, excellent written and verbal communication skills, and experience in pharmaceutical QA validation.
About the Role: As a key member of our team, you will be responsible for ensuring that all equipment, systems, and facilities are qualified and maintained to meet regulatory requirements.
Responsibilities:
* Review and approve qualification protocols for equipment and systems.
* Support qualification activities, including area and drawing walkdowns and vendor interactions.
* Review and approve related documents, including specifications, SOPs, drawings, and support files.
Requirements:
* Bachelor's degree in a relevant field (e.g., engineering, science).
* Minimum 5 years of experience in QA validation.
* Strong understanding of EU and FDA regulations.
* Excellent written and verbal communication skills.