Job Description
................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
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
Work mode: remote