382955BR
Sep 19, 2023
Israel
Job Description
1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing, and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story toward the future. Join Sandoz Israel as the Quality Manager ensuring the local Quality System and Standard Operating Procedures are in place for all current Good Manufacturing Practice /Good documentation practice (cGMP/GDP) and ensuring compliance with regulations, through trainings and internal audits.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
• Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP/GDP (current Good Manufacturing Practice /Good documentation practice) related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits
• Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements
• Ensure that change requests, are managed according to Novartis Standard Operating Procedures from receipt, through to the implementation and closure
• Conduct Good Practice monitoring on all sections, conduct QA investigation for non-compliance, follow up on corrective actions
• Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP (current Good Manufacturing Practice) regulatory and legislative requirements
• Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance
• Ensure that all incoming drug products are inspected prior to their release to the market in accordance with the current in place procedures, registered specifications and local/ international regulations
• Manage complaints, deviations, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures
Your Key Responsibilities:
Your responsibilities include, but not limited to:
• Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP/GDP (current Good Manufacturing Practice /Good documentation practice) related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits
• Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements
• Ensure that change requests, are managed according to Novartis Standard Operating Procedures from receipt, through to the implementation and closure
• Conduct Good Practice monitoring on all sections, conduct QA investigation for non-compliance, follow up on corrective actions
• Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP (current Good Manufacturing Practice) regulatory and legislative requirements
• Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance
• Ensure that all incoming drug products are inspected prior to their release to the market in accordance with the current in place procedures, registered specifications and local/ international regulations
• Manage complaints, deviations, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
What you’ll bring to the role:
• Degree in Pharmacy
• QP certification or minimum of 2 years of experience from Pharmaceutical Industry / plant
• Knowledge of Corrective and Preventive Actions (CAPA), Good Documentation Practice, Quality Management and Quality Assurance
• Hebrew and English – both on proficiency level, Russian – advantage
• Strong digital abilities, Resilience and assertiveness
Desirable Requirements:
• High level of energies, proactiveness, Team player
• Experience from a multi-national company and cross functional interaction
Why consider Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? 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 Sandoz!
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Sandoz are an equal opportunities employer and welcome applications from all suitably qualified persons.
• Degree in Pharmacy
• QP certification or minimum of 2 years of experience from Pharmaceutical Industry / plant
• Knowledge of Corrective and Preventive Actions (CAPA), Good Documentation Practice, Quality Management and Quality Assurance
• Hebrew and English – both on proficiency level, Russian – advantage
• Strong digital abilities, Resilience and assertiveness
Desirable Requirements:
• High level of energies, proactiveness, Team player
• Experience from a multi-national company and cross functional interaction
Why consider Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? 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 Sandoz!
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Sandoz are an equal opportunities employer and welcome applications from all suitably qualified persons.
SANDOZ
COMMERCIAL OPS EUROPE SZ
Israel
Tel Aviv
Novartis Israel
Quality
Full Time
Regular
No
