Posted: 6 December
Offer description
Pharmaceutical Validation Specialist
Job Overview
* The ideal candidate will be responsible for coordinating/directing and actively participating in the validation and quality assurance of site equipment, utilities, processes, and software in compliance with policies, FDA, European cGMP, and GAMP standards.
* This role involves generating/maintaining/executing the Site Validation Master Plan.
* The specialist will also be responsible for generating/maintaining/executing Project Validation Plans and schedules.
* A key aspect of this role is generating validation protocols and final reports to cGMP standards.
Key Responsibilities
* Validation and Quality Assurance: Ensure site equipment, utilities, processes, and software comply with policies, FDA, European cGMP, and GAMP standards.
* Site Validation Master Plan: Generate, maintain, and execute the Site Validation Master Plan.
* Project Validation Plans: Develop and manage Project Validation Plans and schedules.
* Validation Protocols: Create and implement validation protocols and final reports to cGMP standards.
Requirements:
* Bachelor's degree in a relevant field (e.g., engineering, science).
* Prior experience in pharmaceutical validation or a related field.
* Strong understanding of cGMP, FDA, and GAMP regulations.
What We Offer
* A competitive salary package.
* Opportunities for career growth and professional development.
* A collaborative and dynamic work environment.
