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.
We offer:
- Employment at Slovenia’s most reputable employer
- Permanent contract
- Competitive salary and annual bonus
- Hybrid working model
- Relocation support if needed
- Pension scheme and employee recognition programs
- Health & well-being support via the “Energized for Life” initiative
- Unlimited access to learning and development opportunities
Main tasks:
- 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
We expect:
- Bachelor's degree in chemistry, pharmacy, chemical engineering or pharmaceutical technology; PhD in the above or other relevant fields desirable
- Minimum 5 years' experience in manufacturing/production science and technology/technical development/quality
- Proven experience leading validation projects and teams
- Ability to work effectively in a cross-functional environment
- Strong problem-solving and analytical skills
- Strong English communication skills required; familiarity with the local language is a plus
Kariera
Za iskalce
Podjetje
Kariera d.o.o.
Dunajska cesta 165,
1000 Ljubljana