Regulatory Specialist (m/f/d) Pharma

工作内容

Posting Date: Aug 20, 2021

Location:

Karlsruhe, DE

Business Area: Körber Digital

Company: Körber Digital

Do you want to redefine established processes and industries by leveraging IoT, Artificial Intelligence and Industry 4.0 principles? Would you like to be part of a digital solution that increases the quality of pharmaceutical products and, thus, improves the life of millions every day? If your answer is yes, you should continue reading!

With HQ in Karlsruhe, our newest established corporate venture is poised to become the leading end-to-end AI solution provider for quality and performance improvements in pharmaceutical visual inspection. The digitally enabled solution is not just significantly improving inspection procedures using AI but reshapes and simplifies all adjacent processes.

We are data scientists, engineers, designers, product managers, and regulatory compliance experts. We are a team, united by our shared ambition: We exploit the value of data to revolutionize visual inspection to the benefit of all!

Become part of an amazing journey and let us jointly deliver the difference in Pharma!

Your role in our team

As Regulatory Specialist / Pharma QA/QC you are part of the operational organization and responsible for following up on all regulatory aspects and developing our validation strategy fitting all guidelines within the regulated industry

• You are responsible for surveillance and for ensuring compliance of the venture’s products with applicable regulatory requirements
• You will develop the validation strategy for our product to deliver deep learning technology within the regulated pharma industry
• This includes definition, assessment, and verification of functional requirements and validation documentation
• You are our first point of contact for all compliance and data integrity-related questions
• You will be setting up and conducting compliance trainings for the venture’s employees (if necessary)
• You will convince and represent the regulatory compliance and data integrity of our solutions in front of our customers
• You will develop and provide consulting services regarding compliance and data integrity of our software solution
  
  

Your Profile

• You have gained five years of compliance, computer system validation, and data integrity experience in a consulting / training role
• You bring experience with FDA-regulated environments (drug production & inspection, validation) and understanding of the regulatory requirements for pharmaceutical product inspection to the table
• You have excellent knowledge of applicable pharmaceutical regulations and industry guideline including but not limited to:
• US FDA 21 CFR Part 211, 11 and cGMP publications
• EU GMP Guideline and Annex 11
• ICH Q8, Q9, Q10
• You are familiar with:
• Industry guidelines such as ISPE GAMP5 and appropriate industry good practice guidelines
• Relevant Data Integrity guidelines from MHRA, WHO, FDA, ISPE, PIC/S
• You are able to explain and ‘translate’ regulatory verbalizations, and to assess, transfer and map day-to-day software/technical questions to the relevant and applicable regulations
• You have a sound understanding of pharmaceutical processes and expectations of regulated companies
  
  

What we offer

• For you to take responsibility and make an impact from day one
• Growth opportunities on and off the job and a generous individual development budget
• A competitive salary and benefits package, with flexible working hours and remote work options
• Company mobile phone, laptop (MacBook / PC), and other tools you might need