Senior consultant compliance & data integrity

neues Angebot (12/04/2020)

stellenbeschreibung

Job Description Tasks * Responsible for surveying and ascertaining compliance 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 all compliance and DI related questions (internal and external) * Conducting compliance trainings for Werum Employees * Participation in vendor audits and data integrity audits * Representation of compliance and data integrity in Werum's 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 * Provide management support * Assume responsibility to complete projects or activities * Work independently and guide Junior Consultants & Consultants * Mentor new staff members and motivate them with regard to assigned objectives Qualifications * 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 * Sound understanding of pharmaceutical processes and expectations of regulated companies * Self-motivated, energetic and enthusiastic personality * Independent way of working * Strong analytical skills and excellent verbal and written communication skills in German and English * Thorough understanding of the software project life cycle * Severe understanding of the Pharmaceutical environment and regulatory authorities * Ability to work in different roles and collaborate in virtual teams * Ability to collaborate in teams * Willingness to travel internationally (50 to 70%) We offer * International clients and colleagues, dynamic and modern work environment * Flat hierarchies * Attractive and modern work environment, open atmosphere * Perspective to develop in the long term within a company offering complex technical projects Recruitment Team +49 40 21107 291 Werum IT Solutions is the world's leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Werum's PAS-X software product is run by more than half of the world's top 30 pharmaceutical and biotech companies as well as many mid-sized drug manufacturers. Founded in 1969, Werum is headquartered in Lüneburg, Germany, and has locations in Europe, America, and Asia. Werum is part of the Körber Group's Business Area Pharma Systems. The Business Area Pharma Systems provides high quality solutions for the production, inspection and packaging of pharmaceutical products and unites seven internationally successful companies under one roof. The Körber Group is an international technology group with around 10, 000 employees worldwide. 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.

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Senior consultant compliance & data integrity (m/f/d)
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