Compliance and Data Integrity Consultant (m/f/d)

Ideas need initiative.


Werum IT Solutions is the world’s leading provider of software for production control in the pharmaceutical industry. We develop best-in-class IT solutions for the majority of the world’s top 30 pharmaceutical and biopharmaceutical companies around the globe, and also for many regional and mid-sized enterprises. Founded in 1969, Werum has employees at its global HQ in Lüneburg, Germany, at its North American HQ in Parsippany, NJ, at its Asia Pacific HQ in Bangkok, and at many other locations in America, Europe, and Asia. Werum is part of Medipak Systems, the Pharma Systems business area of the international technology group Körber.


The Körber Group is an international technology group with around 10,000 employees all over the world. It unites technologically leading companies with more than 100 production, service and sales locations and offers its customers solutions, products and services in the Business Areas of Körber Digital, Logistics Systems, Pharma Systems, Tissue and Tobacco.

For our location in Dublin we are looking for

Compliance and Data Integrity Consultant (m/f/d)

Tasks:

  • Ensure compliance of the implementation of Werum products to applicable regulatory requirements:

    • Definition, assessment and verification of functional requirements

    • Creation of Process Data Flow Maps based on Business Process Descriptions

    • Providing guidance for software development in our products and projects

    • First contact for compliance and DI related questions (internal and external)

    • Compliance training for Werum Employees

  • Participation in vendor audits and data integrity audits

  • Representation of compliance and data integrity in the Werum user community and international committees

  • Creation of Data Integrity White Papers

  • Development and provision of consulting services regarding compliance and data integrity

  • With respect to compliance and data integrity

    • Consult & train client associates of Werum’s software

    • Understand functionality provided by Werum’s software for the purpose of consulting customers

    • Support projects in all areas of the PAS-X software development lifecycle

  • Assume responsibility to complete projects or activities

  • Work independently and guide Junior Consultants & Consultants

Qualifications:

  • A Bachelor of Science Degree in a Science or Computer Science field is required, a Master of Science Degree is preferred

  • Ten (10)  years of compliance, computer system validation and data integrity experience in a consulting / training role

  • 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, Q12

    • Industry Guidelines such as ISPE GAMP5 and appropriate Industry Good Practice Guidelines

    • Relevant regulatory Data Integrity guidelines from MHRA, WHO, FDA, PIC/S

    • Relevant Data Integrity industry best practice guidelines

  • Ability to explain and ‘translate’ regulatory verbalizations: Assess, transfer and map day-to-day software/technical questions to the relevant and applicable regulation

  • Experience with FDA regulated environments (drug production & validation) and sound understanding of pharmaceutical processes and expectations of regulated companies

  • Self-motivated, energetic and enthusiastic personality, ability to work independently when necessary

  • Strong analytical skills and excellent verbal and written communication skills

  • Thorough understanding of the software project life cycle

  • Very good understanding of the Pharmaceutical environment and regulatory authorities

  • A project management certification (PMP, IPMA) is a plus

  • Experience with Werum’s MES solution PAS-X is a big plus