Qualification & CSV Specialist | Freelancer

We are SGS – the world leader in testing, inspection, and certification. We are recognized as a global benchmark in quality and integrity. Our 99,600 employees operate in a network of 2,600 offices and laboratories, working together to enable a better, safer, and more connected world.

SGS is looking for a Qualification & Validation & CSV Specialist (Freelancer) to collaborate on projects in the pharmaceutical, biotechnology, and medical device industries, ensuring qualification, validation, and compliance activities with GxP/GMP requirements and applicable regulations.

Main responsibilities:

• Execution of qualification activities for equipment, facilities, utilities, and systems.
• Drafting, 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 equipment and computerized systems.
• Support in Change Controls, CAPAs, deviations, and investigations.
• Collaboration with multidisciplinary teams and direct contact with clients.

Requirements:

• Bachelor's/Master's degree 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 drafting validation documentation.
• Fluent English.
• Availability for travel.

Valued skills:

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