Responsible for developing, implementing and managing the site performance qualifications and requalification of existing equipment and cycles as well any new equipment. Responsible for developing, implementing and managing the site process validation, primary packaging validation, process performance qualification, 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 and related SOPs.
Responsible for scale-up cold kits by developing and executing a validation strategy according to cGxP. Executing and managing equipment performance qualifications, requalification, periodic reviews and process, primary packaging, shipping and cleaning validation activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Establish a qualification and requalification program (PQ) for the site and execute activities according to plan and defend to authorities.
• Perform equipment periodic reviews according to internal procedures
• Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities. • Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV).
• Ensure equipment is qualified and manufacturing and cleaning processes are validated; overview on site state of validation is maintained.
• Establish and monitor validation KPIs. Maintain all validation activities in an inspection ready status. • Author validation protocols and reports.
• Establish local procedures & templates for respective validation documentation.
• Ensure that all Site validation activities are performed and are in line with the current requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.
• Support MS&T activities in ensuring that responsible departments execute and maintain the VMP activities. • Partner with Engineering, IT, QC, AS&T to define the interfaces to equipment, utilities and system qualification, analytical method validation. Execute equipment qualification and requalification
• Provide all necessary information to perform the validation documentation, align with stability experts and QC labs to organize the stability samples.
Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role Requirements What you'll bring to the role:
Education: BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable PhD in the above or equivalent.
Languages: Fluent in English and proficient in site local language
Experiences:
• Thorough understanding of manufacturing processes and related process equipment.
• Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
• 5 years experience in executing equipment qualifications, process validation, having led and managed validation projects, including sterile manufacturing. Ideally also experience in manufacturing / manufacturing science and/or technology / technical development / quality.
• Expert in reviewing and writing technical reports.
• Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
• Fundamental understanding of standard pharmaceutical analytical testing.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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