Validation Responsible
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Kalundborg
Are you experienced in validation and project execution? Are you ready to take the lead in ensuring compliance while aiming for simplicity? Join our newly established Project Department in M1 and be part of a cross-disciplinary and innovative matrix organization. We are implementing projects for increased process capacity, in parallel with a running production facility, and we are in search for a new colleague. Apply today for a life-changing career!
The position
As a Validation Responsible, you will:
• Define and execute validation and qualification strategies for projects in Fermentation, Recovery and Purification processes of active pharmaceutical ingredients.
• Develop validation plans, reports, design reviews, and test strategies.
• Implement validation strategies to standardize best practices.
• Train and direct the efforts of less experienced colleagues
• Participate in audits and inspections, identifying and implementing solutions to compliance gaps.
• Possibility for further development within the role into a central position in the project department
Qualifications
To be successful in this role, you should have:
• At least 3 years’ experience with GxP and GEP in complex production processes
• Proven experience in validation planning and project execution within Science and Risk based Validation (SRV) concept and Project Execution Model (PEM)
• Be familiar with user requirement specifications, risk assessments, Design Review and Qualification, system verification.
• Proactive nature with a strong inclination towards decision-making.
• Thrive in a dynamic environment
About the department
M1 Project department is responsible for the investment portfolio and execution of projects in the production facility. The department is organized in a matrix with approx. 150 colleagues executing the portfolio, consisting of many projects in different phases. We will be driving projects worth more than DKK 500 mio. pr. year during the coming years.
You will be part of the Validation team consisting of external consultants and internal employees (Engineering and Operational Responsibles). Our purpose is to work together to deliver high-quality projects while maintaining a fun and collaborative team culture.
Working at
is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at , we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life-changing.
Contact and Deadline
For further information, please contact Associate Manager Tanja Kalstrup +. Deadline is April 14.th.
Applications will be screened on an ongoing basis, and we regularly call for interviews. Please do not hesitate to apply, by simply uploading your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
The position
As a Validation Responsible, you will:
• Define and execute validation and qualification strategies for projects in Fermentation, Recovery and Purification processes of active pharmaceutical ingredients.
• Develop validation plans, reports, design reviews, and test strategies.
• Implement validation strategies to standardize best practices.
• Train and direct the efforts of less experienced colleagues
• Participate in audits and inspections, identifying and implementing solutions to compliance gaps.
• Possibility for further development within the role into a central position in the project department
Qualifications
To be successful in this role, you should have:
• At least 3 years’ experience with GxP and GEP in complex production processes
• Proven experience in validation planning and project execution within Science and Risk based Validation (SRV) concept and Project Execution Model (PEM)
• Be familiar with user requirement specifications, risk assessments, Design Review and Qualification, system verification.
• Proactive nature with a strong inclination towards decision-making.
• Thrive in a dynamic environment
About the department
M1 Project department is responsible for the investment portfolio and execution of projects in the production facility. The department is organized in a matrix with approx. 150 colleagues executing the portfolio, consisting of many projects in different phases. We will be driving projects worth more than DKK 500 mio. pr. year during the coming years.
You will be part of the Validation team consisting of external consultants and internal employees (Engineering and Operational Responsibles). Our purpose is to work together to deliver high-quality projects while maintaining a fun and collaborative team culture.
Working at
is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at , we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life-changing.
Contact and Deadline
For further information, please contact Associate Manager Tanja Kalstrup +. Deadline is April 14.th.
Applications will be screened on an ongoing basis, and we regularly call for interviews. Please do not hesitate to apply, by simply uploading your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Kalundborg.
Jobbet er oprettet på vores service den 3.4.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Projektleder
- Kalundborg
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