LjubljanaCompetitiveHybridFull time0 applicants
About this role
Job Description Summary
Responsibilities
- Review and update quality risk assessments prior to transfer and validation, and adjust control strategies as needed.
- Ensure the availability of all critical technical information and documentation for validation.
- Define pre-validation and validation strategies, including process, cleaning, packaging, and related studies (e.g., hold time for cleaned/uncleaned equipment).
- Coordinate technical, regulatory, and validation batches at the site.
- Review validation protocols and reports.
- Perform local oversight of system changes at the site and ensure their approval and closure.
- Establish project plans for the site, prepare scientifically justified technical strategies with the project team, develop contingency plans, identify obstacles, and propose solutions.
- Assess and plan resource needs at the site and obtain management approval for project costs (e.g., full-time equivalent resources, batch costs, investments, and external expenses), strategies, and timelines.
- Assemble and lead the site project team, set priorities for projects and project team meetings, coordinate activities, and ensure compliance with guidelines.
- What you will bring to the role:
- University degree in pharmacy, chemistry, or another relevant natural science. A master’s degree in the mentioned fields is preferred.
- At least 5 years of relevant experience in pharmaceutical manufacturing is desirable.
- Proficiency in English.
- Knowledge of Microsoft Office tools.
- 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, Back-End Development, Biotechnology, Chemical Engineering, Chemistry, Design Development, Electronic Components, General Hse Knowledge , Incentive Program, Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Leadership, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Npd (New Product Development), Process and Cleaning Validation, Process Control, R&D (Research And Development), Root Cause Analysis (RCA), Software Development, Software Engineering, Technical Leadership, Technology Transfer