Job Purpose :
Responsible for training management and supporting the audits. Responsible for document management and supporting the audits. Establishes and maintains the GxP management system of the PHAD line Units at site level, serves as a contact point between QA and the PHAD Line Units for general inquiries, represents the PHAD in GxP-related initiatives, committees, and networks, if necessary, and collaborates with GMP Officers within global TRD.
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
• Participate in TRD/ Biologics QA TNT network meetings and implement Novartis training strategy.
• Support up4growth and training administrators for implementing simplification strategy.
• Ensure the maintenance of the training classes and curricula for the defined roles/jobs in the PHAD organization in alignment with the team leads, training network lead, and GMP officer(s).
• Support the assignment of the designated training classes and SOPs, training record archival and reporting of individual training completion status
• Support the training teams for the maintenance of the training repository.
• Lead or Member of the PHAD training network
• Optimize existing training methods, procedures and develop more efficient ones by addressing current problems.
2. Documentation Responsible:
• Overall responsible for maintaining the document storage area.
3. Line unit Approver:
• Ensure compliance with relevant regulations, e.g. GMP, HSE, and establish related account-ability within the organization.
• Ensure high quality source documents and dossier modules - where applicable - for regula-tory submissions.
• Supports audits and inspections in terms of deploying the required resources.
4. GMP and Compliance officer:
• Establishes and maintains GMP management system and monitors compliance with internal and external regulations, locally.
• Oversees all GMP activities within the Unit and coordinates the yearly update of the Unit Validation Master Plan as appropriate, locally.
• Represents the PHAD Line Units in GMP related initiatives, networks, and ensures alignment on global level as appropriate.
• Supports GMP training programs for Unit staff in coordination with other functions and monitors overall training status, locally.
• Prepares, performs and supports GMP audits as appropriate, including organizing and tracking any follow-up action items, locally.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Education and Experience:
• M.Sc. /M. Pharm/ Ph.D. with relevant experience.
• Minimum 10 years of successful industry experience in the GxP, Training, and development of pharmaceutical formulations.
• Recognized expertise in a GxP area and broad scientific as well as technical and strategic background.
• Demonstrated successful experience with working in interdisciplinary and cross-cultural teams.
• Thorough knowledge of relevant SOP, GMP and Novartis regulations and policies if applicable.
• Basic understanding of development activities and pharmaceutical processes.
• Good knowledge on various training delivery tools and techniques; good computer and software skills
• Excellent communication/presentation skills and scientific.
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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