Vodja validacij (m/ž/d) / Validation Lead (m/f/d)

About this role

Responsibilities

• Develop and execute validation strategies for processes, cleaning, packaging, and ongoing process verification.
• Ensure validation compliance with GMP, internal policies, legislation, and quality standards.
• Establish and maintain the site validation master plan and monitor validation status.
• Prepare validation protocols and documentation and lead validation activities.
• Advise on risk assessments and validation strategies for new product introductions.
• Participate in product transfers and launches and support registration documentation preparation.
• Coordinate with Engineering, IT, QC, and AS&T departments on qualifications and validations.
• Host validation board meetings and represent the site in the validation network.
• Support training and development of team members and manage training curricula.
• Support implementation of Novartis manufacturing practices and ensure business continuity.
• What you will bring to the role:
• University degree in natural sciences, pharmacy, or technical field.
• Experience in process, cleaning, and packaging validation in a regulated environment.
• Strong knowledge of GMP requirements and pharmaceutical legislation.
• Ability to prepare validation documentation and lead validation activities.
• Experience collaborating with departments such as IT, QC, and Engineering.
• Risk assessment skills and familiarity with risk management tools.
• Fluent in English, both written and spoken. Fluent in Slovenian language is an advantage.
• We offer
• permanent employment
• with
• 6 months
• of probation period.
• Benefits and Rewards:
• Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, possibility of joining collective health insurance scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical and mental well-being and managing workload (Well-being), 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.
• Join our Novartis Network:
• If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
• https://talentnetwork.novartis.com/network
• Skills Desired
• Applied Statistics, Change Control, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process and Cleaning Validation, Process Control, Quality Compliance, Regulatory Compliance, Resilience and Risk Management, Technical Leadership, Technology Transfer