Quality Assurance Specialist Sandoz, Holzkirchen (Munich) Germany

Job description

Job Description

Job Summary

Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people’s lives?
Sandoz International is now hiring a Quality Assurance Specialist to support the development, implementation, and maintenance of the Quality Management System (QMS) for Sandoz Small Molecules Product Development (SSM PD).
Job purpose

The position holder will be responsible for implementation and tracking of: (1) Quality standards and procedures, respective action progress, (2) Training and document management system to ensure compliant execution of GMP, GCP, and GDevP processes globally and locally (in the Sandoz Development Centers (SDCs)).
Key Responsibilities
• Support the definition of the relevant QMS framework (e.g. document management system and training system).
• Support the follow-up to the implementation of the Novartis Quality Manual, Novartis/ Sandoz quality standards/ policies/ guidelines in SSM PD globally and locally as appropriate.
• Support the compilation and implementation of respective GOPs and SOPs.
• Support the implementation of the Quality Plan (Q-Plan) and Quality Risk Assessments.
• Support the preparation of key figures/ key performance indicators (KPIs) report for the business/ senior management.
• Support the compilation of the training matrices for all global functions in SSM PD as applicable.
• Interface/ interact with the relevant quality function in SSM PD (including SDCs) as well as NTO, GDD.

About Sandoz:

About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2016 sales of USD 10.1 billion. In 2016, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s greater Munich area.

Benefits of Working for Sandoz
• Competitive salary
• Performance based annual bonus
• Work/ life balance
• Pension scheme
• Life insurance
• Medical Health Insurance
• Paid annual leave
• Additional benefits

‘I came for the job, I stay for the culture’

Desired profile

Minimum requirements

The ideal candidate will have

• Degree in Natural Science (e.g. Pharmacy, Chemistry, Biology) or comparable natural scientific education
• German and English business fluent
• Verry good MS Office skills
• Knowledge of GMP regulatory requirements.
• Minimum 3 years of experience within the pharmaceutical industry, e.g. in the area of Quality Management Systems
• Quality mind-set, always looking for improvement and best practice and experience in an international operation environment
• Familiar with ICH guidelines (e.g. ICH Q7, Q8, Q9, and Q10), FDA-regulations (21CFR 210-211, Part 4) and EU-regulations is a plus

We focus on creating an inclusive organisation and welcome people who have different knowledge, perspectives, experience, and working styles from across the global population.