Senior Sterility Assurance Expert (m/f/d) / Višji strokovnjak za zagotavljanje sterilnosti (m/ž/d)

Job Description Summary

#LI-Hybrid

We are thrilled to announce the establishing of new clinical manufacturing facility in Slovenia, dedicated to accelerating the creation of innovative medicines for patients around the globe. Don’t miss the chance to join our international team.
As Senior Sterility Assurance Expert Drug Supply you will be part of our Drug Product Clinical Manufacturing Team at our Technical Research and Development site in Menges, Slovenia and be primarily responsible for ensuring sterility assurance and contamination control at the Clinical Manufacturing Plant.

Job Description

 JOB DESCRIPTION:

Key Responsibilities:

• Sterility assurance and contamination control within the Clinical Manufacturing Plant.
• Investigation of microbiological related deviations / OOX, conducting root cause analysis, and implementation of CAPAs and corresponding Risk Assessment.
• Contribution in the preparation and execution of validations (clean room validation, aseptic process validation), including process and environmental monitoring.
• Providing technical expertise during regulatory inspections and ensuring compliance with regulatory requirements.
• Developing and improving cleaning, sanitation, and environmental monitoring programs.
• Cross-Functional Collaboration to align activities with organizational goals.
• Mentoring and providing technical guidance to junior team members.
• Utilizing data analytics, machine learning, and artificial intelligence to optimize performance parameters.
• Proactive review and improvement of aseptic programs and contamination control strategies.

Essential Requirements:

• Accountability: responsibility for assigned tasks and reliability.
• Decision Making: correct interpretation of analyses and evaluations and identifying appropriate measures to be taken.
• Ability to work in a team (constructive and reliable contribution in a group setting) and in a matrix environment. Influencing without authority.
• Results driven self-motivation and motivation of others to achieve outstanding results while ensuring adherence to ethical and legal principles, with a continuous drive for improvement.
• Customer focus as the highest priority.
• Quality focus: providing the highest quality products and services that meet the needs and requirements of internal and external customers.
• Significant experience in CMC development and/or production.
• 5 years of experience in Pharmaceutical Industry and 3 years of Microbiological Experience; thorough knowledge of cGMP requirements

Desirable Requirements:

• 2 years of experience within Manufacturing QA

We offer permanent employment with 6 months of probation period. Submit your application with the CV in English language.

You’ll receive:     

Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Wellbeing), employment at Top SI Employer, Unlimited learning and development opportunities.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired