GlycoThera Analytics GmbH has been successfully providing analytical services for more than 20 years. Our clients are leading pharmaceutical companies specializing in biologics and biosimilars. Our comprehensive analytical service covers all phases of the product life cycle, from laboratory-scale development to market approval and batch release.
Our strengths lie in method development, product characterization, validation and release and stability testing. We work according to the highest GMP standards and ICH guidelines to ensure that our customers meet regulatory requirements. With our many years of experience and expertise, we support our customers in meeting the highest quality standards and successfully bringing their products to market.
To expand our team, we are looking for a Computer System Validation Expert (all genders). The position is part of the Quality Assurance Department and reports to the head of the Quality Unit. Your main tasks include:
Management and coordination of validation activities:
Planning, implementation and monitoring of validation projects for computerised systems.
Ensuring compliance with regulatory requirements (e.g. FDA, EMA) and internal guidelines.
Develop and implement validation strategies:
Create and maintain validation plans, protocols and reports.
Develop risk management strategies to identify and mitigate potential risks.
Collaboration with other departments:
Close collaboration with IT, quality control, and other relevant departments.
Support in the implementation of new systems and technologies.
Audit and inspection preparation:
Preparation and support of internal and external audits and inspections.
Remedy of identified deficiencies and implementation of corrective measures.
Completed studies in computer science, engineering, natural sciences or a related field.
5+ years of experience in validating computerised systems in the pharmaceutical or biotechnology industry.
In-depth knowledge of the relevant regulatory requirements and standards (e.g. GAMP 5, 21 CFR Part 11).
Analytical thinking and problem-solving skills.
Ability to work in a dynamic and interdisciplinary environment.
Very good written and spoken English skills.
Good knowledge of German is an advantage.
We offer you an innovative environment that impresses with a motivated team and very good performance. We also attach great importance to the personal development of our employees, as well as mutual respect and reliability.