Aktuelle Jobs im Zusammenhang mit Regulatory Compliance Specialist - Munich, Bayern - ARCONDIS
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Chemical Regulatory Compliance Specialist
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Regulatory Compliance Specialist
vor 3 Wochen
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Chemical Regulatory Compliance Specialist
vor 4 Wochen
Munich, Bayern, Deutschland tozero VollzeitAbout the RoleWe are seeking a highly skilled Chemical Regulatory Compliance Specialist to join our team at tozero, a leading deep-tech startup specializing in lithium-ion battery recycling. As a key member of our team, you will play a crucial role in ensuring our operations comply with relevant regulations and standards.Key ResponsibilitiesDevelop and...
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Chemical Regulatory Compliance Specialist
vor 4 Wochen
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Chemical Regulatory Compliance Specialist
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Chemical Regulatory Compliance Specialist
vor 1 Monat
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Regulatory Affairs Specialist
vor 2 Wochen
Munich, Bayern, Deutschland ONCARE GmbH VollzeitJob DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ONCARE GmbH. As a key member of our Quality and Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for our medical devices.Your primary focus will be on performing gap analyses of regulatory documents and...
Regulatory Compliance Specialist
vor 2 Monaten
About the Role
At ARCONDIS, we are seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring that our laboratory and production processes meet the highest standards of quality and regulatory compliance.
Key Responsibilities
- Develop and implement qualification and validation plans for laboratory and production-related processes
- Prepare and review specifications and risk analyses to ensure compliance with regulatory requirements
- Ensure the accuracy and integrity of GMP-compliant documentation
- Plan and execute IQ-OQ-PQ activities to ensure the quality and reliability of our equipment and processes
- Process changes and deviations in a timely and efficient manner
- Develop and maintain Standard Operating Procedures (SOPs) to ensure consistency and compliance
- Maintain and archive documents to ensure easy access and compliance
- Provide training and ensure training standards are met to ensure a high level of quality and compliance
- Support pharmaceutical release laboratories in GMP activities to ensure compliance and quality
- Contribute to business development by identifying opportunities for process improvements and implementing changes to ensure compliance and quality
Requirements
- Bachelor's degree in pharmaceutical sciences, biotechnology, engineering, or chemistry
- Practical experience in a pharmaceutical laboratory or production environment
- Practical experience in quality management
- Excellent knowledge of GMP and regulatory requirements
- Experience in the qualification of laboratory equipment and facilities
- Experience in method validation of analytical methods
- Experience in LIMS or MES environment is an advantage
- Careful, self-contained, and responsible way of working
- Excellent verbal and written communication skills in German and English
- Strong experience in working with computer systems
- High degree of quality awareness, strong communication skills, and ability to work in interdisciplinary teams
- Willingness to travel
