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Turhan

Recruiting, HR

Compliance Services - Frankfurt / Basel

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.

We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.

Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.

We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.

Qualification of Equipment, instruments and facilities

Preparation of qualification and validation plans for laboratory and production-related processes

Preparation and review of specifications and risk analyses

Planning and witness SAT, FAT

Planning and execution of IQ-OQ-PQ

Processing of changes and deviations

Creation of Standard Operating Procedures (SOPs)

GMP-compliant documentation

Maintenance and archiving of documents

Ensuring training standards

Support of pharmaceutical release laboratories in GMP activities

Support in business development

Successfully completed scientific or technical studies (for example: Pharmacy, MedTech, Biotechnology, Engineering, Chemistry) or technical apprenticeship

Practical experience in a pharmaceutical laboratory, MedTech or production environment

Very good GMP knowledge and in-depth knowledge of other regulatory requirements

Practical experience in quality assurance

Professional experience in qualification of laboratory equipment and facilities is an advantage

Experience in method validation of analytical methods is an advantage

Experience in LIMS or MES environment is an advantage

Careful, self-contained, and responsible way of working

Very good German and good English language skills as well as strong experience in working with computer systems

High degree of quality awareness, strong communication skills and the ability to work in interdisciplinary teams

Willingness to travel