GMP Compliance Manager Engineering (m/f), Schaftenau, Austria
3000! This is the number of SOPs (Standard Operating Procedures), working procedures for manufacturing of high quality biopharmaceutical products; compliance with regulations. As Compliance Manager (w / m / d), you ensure compliance with all technical quality requirements, both in the context of investment projects and during ongoing operations.
Your responsibilities include, but not limited to:
• Ensure technical GMP compliance with national regulations, Novartis guidelines, procedures and standards
• Support of audits and inspections reviews including follow-up measures performed by authorities, Novartis Global Compliance Auditing and external customer
• Act as contact person regarding technical GMP compliance questions within engineering and interface to Campus and site QA-departments as well as the Campus Compliance Engineers
• Coordination, harmonization and standardization of technical GMP compliance activities, systems, tools and compliance standards (e.g. CFR, EU GMP Guide, WHO, ICH and ISPE, Rollout and implementation of technical initiatives and projects)
• Support of contractor management activities within Site Engineering
• Continuous improvement of technical processes and standards
• Performance of engineering compliance checks, preparation of the corresponding reports as well as follow-up regarding timely closure of CAPAs to observations
What you'll bring to the role:
• Respective HTL-graduation (e.g. chemical, mechanical or electrical engineering, technical IT) incl. 3-4 of professional experience / technical degree (Bachelor / Master) in one of the following studies: chemical, process, mechanical, electrical, automation, food process or environmental engineering, biotechnology, mechatronics, biochemistry, life science
• German - fluently, English - very good
• Professional experience within the areas of plant or project engineering, mechanical engineering, automation engineering and/or technical quality assurance preferred
• Experience concerning qualification / validation desirably
• Experience in matrix and/or indirect people management role with solid ability to influence without authority successfully
Contact: Jennifer Kriedemann, Talent Acquisition & Staffing Business Partner, +44 7525 702920
Why consider Novartis?
750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR 50,374.38EUR per year on a full time basis).
We are Novartis. Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Ihre Aufgaben: Sind unter anderem: • Sicherstellung der Compliance innerhalb des zugewiesenen Verantwortungsbereich (Logistik Bereiche innerhalb der Drug Subsatance / Drug Product Herstellung von Arzneimittel...
Your responsibilities: Your responsibilities include, but not limited to: • Write and maintain high-quality regulatory documentation during development, registration and post-marketing, respecting established guidelines...