GxP / CSV合规顾问 (制药和生物制药)

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For our client in Germany (fully remote within Germany), we are looking for an GxP / CSV Compliance Consultant (Pharma & Biopharma).
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

Originally posted on Himalayas