QA Specialist with experience in biotechnology and quality oversight of external partners
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Ballerup
Do you want to use your process knowledge within biotechnology to practice quality oversight of our Contract Manufacturing Organizations?
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. Part of this journey involve strategic alliances with external partners, for example Contract Manufacturing Organizations (CMO). You will be part of the External Manufacturing & Suppliers Quality department in Global Quality and contribute to activities within Supplier Quality Management related to biotechnological and drug-device combination products.
In LEO Pharma you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
Your responsibilities will be to ensure quality oversight of the manufacturing activities at CMOs and release products to the markets. You will collaborate both with internal stakeholders at LEO Pharma and with stakeholders at the different CMOs.
You will
Your position will be in Ballerup, Greater Copenhagen. You should expect around 15-20 days of travelling yearly to CMOs.
Your qualifications
We are looking for a profile with drive and an open minded and positive approach that supports collaboration across different areas. You possess excellent written and oral communication skills, including English, at a proficient level. You have a strong quality mindset and can accurately analyze complex situations and recommend how to handle these situations to ensure patient safety, product quality and compliance. You have a continuous improvement mindset.
Your new team
You will join a great team of skilled colleagues who are quality experts with focus on Supplier Quality Management and quality oversight of different supplier categories. We collaborate with other departments in Global Quality and Global Biologics & External Manufacturing, Procurement, Pharmaceutical Design and Development, Regulatory Affairs and with external suppliers.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Arslan Nejadi, Senior Director, External Manufacturing & Suppliers Quality at +45 21 47 48 54.
. Applications will be evaluated, and interviews held on an ongoing basis until the right candidate is identified. The deadline is 11 October 2021.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. Part of this journey involve strategic alliances with external partners, for example Contract Manufacturing Organizations (CMO). You will be part of the External Manufacturing & Suppliers Quality department in Global Quality and contribute to activities within Supplier Quality Management related to biotechnological and drug-device combination products.
In LEO Pharma you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
Your responsibilities will be to ensure quality oversight of the manufacturing activities at CMOs and release products to the markets. You will collaborate both with internal stakeholders at LEO Pharma and with stakeholders at the different CMOs.
You will
- practice quality oversight of externally manufactured products, including establishment and update of quality agreements between LEO Pharma and CMOs
- perform confirmation of partial manufacturing of intermediate or bulk products manufactured by LEO Pharma’s contract manufacturers and make final batch release of contract manufactured products
- act as QA for activities related to external manufacturing, handle quality events and provide GMP support to stakeholders
- participate in different projects related to outsourcing activities
- build and share knowledge related to area of responsibility
Your position will be in Ballerup, Greater Copenhagen. You should expect around 15-20 days of travelling yearly to CMOs.
Your qualifications
- Preferably a Masters’ degree in natural science, for example pharmacist or engineer
- 8+ years of experience from the pharmaceutical industry
- Solid and up-to-date knowledge of biopharmaceutical drug substance and drug product processes and with drug-device combination products
- Solid and up-to-date knowledge of GMP requirements
- Experience from working within a quality organization
- Experience as Qualified Person (QP)
We are looking for a profile with drive and an open minded and positive approach that supports collaboration across different areas. You possess excellent written and oral communication skills, including English, at a proficient level. You have a strong quality mindset and can accurately analyze complex situations and recommend how to handle these situations to ensure patient safety, product quality and compliance. You have a continuous improvement mindset.
Your new team
You will join a great team of skilled colleagues who are quality experts with focus on Supplier Quality Management and quality oversight of different supplier categories. We collaborate with other departments in Global Quality and Global Biologics & External Manufacturing, Procurement, Pharmaceutical Design and Development, Regulatory Affairs and with external suppliers.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Arslan Nejadi, Senior Director, External Manufacturing & Suppliers Quality at +45 21 47 48 54.
. Applications will be evaluated, and interviews held on an ongoing basis until the right candidate is identified. The deadline is 11 October 2021.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 8.9.2021, 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.
- Produktspecialist
- Ballerup
- Mandag den 11. oktober 2021
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