GxP / CSV Compliance Consultant (Pharma & Biopharma)

Coopers Group; Schlieren; On-site; CHF 110,000 - 170,000; Full time

Job summary

Coopers Group in Switzerland seeks an experienced regulatory/compliance specialist to guide GxP compliance and oversee CSV validations. The role emphasizes GAMP 5 application, change control design, and evaluating system changes for regulatory impact.

You will assess make-or-buy decisions from a compliance perspective and review proposed solutions to ensure GxP alignment, working closely with project teams and stakeholders. English language is mandatory; German is a plus.

Qualifications

• Several years of experience in a regulated pharmaceutical or biopharmaceutical environment.
• Strong knowledge of GxP and applicable regulatory requirements.
• Hands-on experience in Computerized System Validation (CSV).
• Thorough understanding of the GAMP 5 framework and its application.
• Experience advising on and designing change control processes.
• Ability to evaluate technical solutions from a compliance perspective.

Responsibilities

• Provide expert guidance and support on GxP compliance in pharma environments.
• Support the validation of computerized systems (CSV) per regulatory requirements.
• Apply and guide GAMP 5 principles and validation guidelines.
• Collaborate on design and optimization of change control processes.
• Assess planned system changes for impact on compliance and validation.
• Evaluate make-or-buy decisions from regulatory and compliance perspectives.
• Review concepts and proposed solutions for alignment with GxP.
• Collaborate with project teams to ensure regulatory compliance throughout activities.

Skills

GxP compliance

CSV validation

GAMP 5

Change control

Make-or-buy

Regulatory knowledge

Analytical thinking

English required

German a bonus

Tools

CSV tooling

Job description

Your Tasks:

• Provide expert guidance and support on GxP compliance within pharmaceutical and biopharmaceutical environments
• Support the validation of computerized systems (CSV) in accordance with applicable regulatory requirements
• Apply and provide guidance on GAMP 5 principles and relevant validation guidelines
• Contribute to the design and optimization of change control processes
• Assess planned system changes regarding their impact on compliance and validation requirements
• Evaluate make-or-buy decisions from a regulatory and compliance perspective
• Review existing concepts and proposed solutions to ensure alignment with GxP requirements
• Collaborate closely with the project team to ensure regulatory compliance throughout project activities
• Support the development of appropriate compliance and validation approaches for computerized systems

Your Profile:

• Several years of experience in a regulated pharmaceutical or biopharmaceutical environment
• Strong knowledge of GxP and applicable regulatory requirements
• Hands-on experience in Computerized System Validation (CSV)
• Very good understanding of the GAMP 5 framework and its application to computerized systems
• Experience in advising on and designing change control processes
• Ability to evaluate technical solutions and make-or-buy decisions from a compliance perspective
• Good understanding of computerized systems and their regulatory requirements
• Strong analytical and conceptual thinking skills
• Independent, structured, and solution-oriented approach to work
• Excellent communication and consulting skills
• Very good English skills are mandatory, German language skills are an advantage