Head Manufacturing Compliance (m/f)
247532BR
Head Manufacturing Compliance (m/f)
• Assurance of information flow regarding quality and compliance matters from the site
• Review, evaluate and implement Novartis Quality Modules (QMs) and system/site SOPs
• Operational support for the manufacturing units in dealing with compliance items, implementation of CAPAs, and validation coordination
• Participate in Quality Governance Meeting & other compliance-related meetings
• Support to fulfill Sandoz Quality Plan, including Site Quality Risk Assessment (SQRA)
• Initiate and coordinate projects and measures to close potential GMP gaps in order to maintain and improve overall GMP compliance status
• Prepare, review and approve of GMP relevant documents like risk assessments or validation/ qualification protocols
• Participate and follow-up of Health Authority Inspections, GCA audits and self-inspections
• Review, evaluate and implement Novartis Quality Modules (QMs) and system/site SOPs
• Operational support for the manufacturing units in dealing with compliance items, implementation of CAPAs, and validation coordination
• Participate in Quality Governance Meeting & other compliance-related meetings
• Support to fulfill Sandoz Quality Plan, including Site Quality Risk Assessment (SQRA)
• Initiate and coordinate projects and measures to close potential GMP gaps in order to maintain and improve overall GMP compliance status
• Prepare, review and approve of GMP relevant documents like risk assessments or validation/ qualification protocols
• Participate and follow-up of Health Authority Inspections, GCA audits and self-inspections
Education: University degree in Biotechnology, (Bio) Chemistry, Process Engineering or similar
Languages: fluent in German and English
Experience: minimum of 5 years work experience in the GMP environment in the (bio)pharmaceutical industry, ideally experience with API production (Manufacturing, QA, Compliance aspects) and audit experience, good understanding of regulations and guidelines, strong analytical and conceptual thinking, good communications skills are required.
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 € 65,418.08 per year)
Languages: fluent in German and English
Experience: minimum of 5 years work experience in the GMP environment in the (bio)pharmaceutical industry, ideally experience with API production (Manufacturing, QA, Compliance aspects) and audit experience, good understanding of regulations and guidelines, strong analytical and conceptual thinking, good communications skills are required.
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 € 65,418.08 per year)
Novartis Technical Operations
NTO BTDM
Austria
Schaftenau
Sandoz GmbH
Quality
Full Time
Regular