GMP Qualification Consultant
vor 4 Wochen
We are seeking a skilled professional to become part of our team as a Validation Specialist. In this position, you will take charge of preparing essential documentation for the qualification of pharmaceutical process equipment and will conduct qualifications at client locations. Your role will be pivotal in ensuring adherence to current GMP regulations and fulfilling customer expectations in both pharmaceutical and biotechnology projects. Collaboration with various stakeholders throughout all project stages, including suppliers, engineers, and operators, will be key to your success.
Key Responsibilities:- Developing GMP risk assessments and qualification strategies
- Planning and executing qualifications for production machinery, cleanroom environments, and utility systems
- Documenting qualification findings and reports
- Reviewing supplier documentation and coordinating supplier-related activities
- Ensuring that all documentation is compliant with GMP standards
- Managing changes and deviations effectively
- Maintaining and archiving essential documents
- Providing support and technical guidance to project teams on GMP-related matters
- Completing quality assurance responsibilities
- A degree in natural sciences, pharmacy, chemical engineering, or a related field, or relevant experience in qualification/validation within the pharmaceutical sector
- Familiarity with validation processes, particularly computerized systems validation (CSV), is a plus but not essential
- Proficient in both German and English
- Strong analytical abilities, proactive attitude, and adaptability
- Ability to work independently with attention to detail
- Willingness to travel as required
To excel in this role, effective teamwork, assertiveness, and strong communication skills are essential. You should be capable of understanding customer needs and demonstrating leadership in client interactions.
What We Provide:- Diverse and engaging tasks in a dynamic work environment
- Opportunities for professional growth in a rapidly expanding organization
- Access to various internal training and development programs
- A collaborative work atmosphere that encourages innovative ideas
- Modern office facilities with ergonomic workspaces and multifunctional areas
- Attractive recreational activities and team-building initiatives
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