Job Description Summary
The future is ours to shape!
Job Description
Sandoz, of which Lek is also a part, is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz and Lek associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
As Validation Lead you will be responsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations.
Join us as a Founder of our ‘new’ Sandoz and Lek!
Your key responsibilities:
Your responsibilities include, but not limited to:
Defining and implementing the validation strategy (process, cleaning, media status times, SIPs, product transport, periodic validation checks) and advocacy to the relevant authorities.
Overall responsibility for establishing, prioritizing, implementing and tracking the validation master plan for process validation, cleaning, packaging, validation of media/medium residence times and chromatography media use cycles, and periodic process validation verification (OPV), periodic check of cleaning validation statuses.
Ensuring that all production and purification processes and other supporting processes are validated and that a validation status review is maintained on site.
Preparation of more complex validation protocols, participation and review of the preparation of all validation documentation.
Ensuring that all validation activities are carried out on site and that they comply with applicable Sandoz requirements and current GMP guidelines and regulatory requirements, addressing deviations related to these activities, including oversight of validation preparations and validation resulting from technical changes.
You are the host of the validation team.
In collaboration with Engineering, IT, QC, AS&T units, identify contact persons for equipment/infrastructure qualification, systems qualification, media, analytical methods validation.
Participation in the provision of process data obtained during validation to be used for the preparation of registration dossiers.
Representing the site in global validation teams.
What you will bring to the role:
Bachelor's degree in chemistry, pharmacy, chemical engineering or pharmaceutical technology. PhD in the above or other relevant fields desirable.
Active knowledge of English.
Knowledge of Microsoft Office tools.
Minimum 5 years' experience in manufacturing/production science and technology/technical development/quality.
You’ll receive:
Employment at the most reputable employer in Slovenia offers 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 (Energized for Life), Unlimited learning and development opportunities.
Possible job locations: Slovenia (Lendava)
We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by 06.10.2024.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool
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Skills Desired
