Engineer as GMP Compliance Manager - Quality Assurance (m/f/d)

Posted on Mar 15, 2019 by Novartis, Sandoz GmbH

Kundl, Tirol Austria
Engineering
13 Mar 2019
Annual Salary
Full-Time
GMP Compliance Manager (m/f)
Join us to find new ways to improve and extend people's lives! As part of the global Novartis Group our sites in Kundl, Schaftenau, Unterach and Vienna are specialized in development, production and distribution of pharmaceutical products. Area of Responsibility • Assurance of compliance to cGMP within the assigned area of responsibility (e.g. automation & control)
• Implementation of standardized / harmonized GMP-relevant engineering processes, implementation of best practice procedures and systems within the assigned area of responsibility
• Establishment, review / approval of engineering-relevant building specific-, site- or system-SOPs, performance of gap assessments and establishment of CAPA-plans in order to facilitate the implementation of new / revised procedures
• Representation of the Aseptics & Biotechnology Engineering Compliance Management in engineering department meetings within Aseptics & Biotechnology as well as cross-functional engineering meetings with other business units
• Expert / single point of contact for all GMP-related questions within the assigned area of responsibility
• Assumption of the role as qualification coordinator within the assigned area of responsibility during expansion / improvement projects as well as review and approval of all qualification documents
• Performance of compliance checks, preparation of the corresponding report as well as follow-up regarding timely closure of CAPAs to observations within the assigned area of responsibility
• Support of all engineering-units during audits and inspections; i.e. preparation, attendance and follow-up Qualification Education: Higher technical education in Engineering
Languages: German - fluent in spoken and written English - fluent in spoken and written
Experience: Work experience (2-3 years) as Automation Engineer, Plant Engineer, Project Engineer, technical Quality Assurance preferred, Experience concerning qualification / validation preferably
Please apply online under the following link Online Application (Job ID 261874BR).
Contact: Denys Sapiton, Senior Recruiter

Reference: 671251370

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