Qualification & CSV Specialist | Freelancer

About the Position

Qualification & CSV Specialist | Freelancer

SGS, a global leader in testing, inspection, and certification, is seeking a Qualification & CSV Specialist (Freelancer) to collaborate on projects in the pharmaceutical, biotechnological, and medical device industries. This role ensures activities of qualification, validation, and compliance with GxP/GMP requirements and applicable regulations.

Responsibilities

• Execution of qualification activities for equipment, facilities, utilities, and systems.
• Development, execution, and review of DQ, IQ, OQ, and PQ protocols.
• Development and execution of CSV activities according to GAMP 5 and GMP.
• Preparation of technical validation documentation (URS, Risk Assessments, Validation Plans, Test Scripts, and Reports).
• Participation in implementation and validation projects for computerized equipment and systems.
• Support in Change Controls, CAPAs, deviations, and investigations.
• Collaboration with multidisciplinary teams and direct contact with clients.

Requirements

• Degree/Master's in Engineering, Pharmaceutical Sciences, Biotechnology, or a similar field.
• Minimum of 2 years of experience in Qualification & Validation and/or CSV.
• Knowledge of GMP/GxP, GAMP 5, and Annex 11.
• Experience in preparing validation documentation.
• Fluent English.
• Availability for travel.

Nice to Have

• Technical rigor and attention to detail.
• Analytical and problem-solving skills.
• Organization, autonomy, and priority management.
• Excellent communication and interpersonal skills.
• Client and results orientation.

We Offer

• Opportunity to work with a global leader in testing, inspection, and certification.
• Collaborate on impactful projects in the pharmaceutical, biotechnological, and medical device industries.
• Flexible freelance position.

About the Company

SGS is a world leader in testing, inspection, and certification. With 99,600 employees operating in a network of 2,600 offices and laboratories, we work together to enable a better, safer, and more interconnected world.