-
Quality Assurance for Aseptic CMO's
Fundet i: Talent DK C2 - for 6 dage siden
Novo Nordisk Søborg, DanmarkThe position · Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support for outsourced production activities worldwide. You will have the opportunity to make a difference for thousands of patients around the world by ensuring a high level o ...
-
Quality Assurance for Aseptic CMO's
Fundet i: Talent DK C2 - for 6 dage siden
Novo Nordisk Søborg, DanmarkGlobal Contract Manufacturing (GCM) Quality Assurance (QA) is responsible for quality assurance and quality support for outsourced production activities worldwide. We are looking for a QA professional like you, with a high level of dedication, communication skills and quality min ...
-
Specialist in Validation and Technology Transfer
Fundet i: Talent DK C2 - for 4 dage siden
Novo Nordisk A/S Søborg, DanmarkAre you ready to take on a new challenge and make a significant impact on Novo Nordisk's bottom line? Would you like to set direction and collect knowledge in a newly established department? Do you enjoy collaborative work in an international environment? · If so, we are looking ...
-
Senior Professional, Aseptic Process Drug Product MSAT
Fundet i: Talent DK C2 - for 4 dage siden
Novo Nordisk A/S Søborg, DanmarkDo you have a passion for production and enjoy working with many stakeholders both internally and externally? Would you like to bridge the gap between our internal sites and our Contract Manufacturing Organisations (CMOs) to ensure consistency across our operations? · Then look n ...
-
Specialist in Validation and Technology Transfer
Fundet i: Talent DK C2 - for 4 dage siden
Novo Nordisk Søborg, DanmarkThe position · As a Specialist in Validation and Technology Transfer for CMO and Expansion Projects, you will be part of impactful projects that are global, cross-functional, and of strategic priority. You will work closely together with project managers and other specialists bo ...
-
Senior Professional, Aseptic Process Drug Product MSAT
Fundet i: Talent DK C2 - for 4 dage siden
Novo Nordisk Søborg, DanmarkDo you have a passion for production and enjoy working with many stakeholders both internally and externally? Would you like to bridge the gap between our internal sites and our Contract Manufacturing Organisations (CMOs) to ensure consistency across our operations? · Then look n ...
-
Specialist in Validation and Technology Transfer
Fundet i: Talent DK C2 - for 4 dage siden
Novo Nordisk Søborg, DanmarkAre you ready to take on a new challenge and make a significant impact on Novo Nordisk's bottom line? Would you like to set direction and collect knowledge in a newly established department? Do you enjoy collaborative work in an international environment? · If so, we are looking ...
-
Senior Professional, Assembly
Fundet i: Talent DK C2 - for 4 dage siden
Novo Nordisk A/S Søborg, DanmarkAre you enthusiastic about production and enjoy collaborating with numerous stakeholders, globally? Do you thrive in facilitating seamless coordination between our internal sites and Contract Manufacturing Organisations (CMOs) to uphold operational consistency? · Then look no fur ...
-
Senior Professional, Assembly
Fundet i: Talent DK C2 - for 4 dage siden
Novo Nordisk Søborg, DanmarkAre you enthusiastic about production and enjoy collaborating with numerous stakeholders, globally? Do you thrive in facilitating seamless coordination between our internal sites and Contract Manufacturing Organisations (CMOs) to uphold operational consistency? · Then look no fur ...
-
Scientist Drug Product
Fundet i: Talent DK C2 - for 4 dage siden
Ascendis Pharma Hellerup, Danmark FuldtidWork on late stage and commercial projects in a fast-growing biotech company · As Scientist Drug Product at Ascendis Pharma the primary tasks are to ensure that our commercial Drug Products are produced and delivered in accordance with current legislation and approvals. You will ...
-
Director Drug Product Manufacturing
Fundet i: Talent DK C2 - for 4 dage siden
Ascendis Pharma A/S Hellerup, Danmark FuldtidWork on late stage and commercial projects in a fast-growing biotech companyAs Director in Drug Product Manufacturing, you will head up the drug product manufacturing department responsible for the Life Cycle Management (LCM) of commercial drug product and hence all drug product ...
-
Senior QA Professional with CMO expertise
Fundet i: Talent DK C2 - for 4 dage siden
Novo Nordisk Bagsværd, DanmarkDo you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? If so, we have an exciting possibility waiting for you as Sen ...
Quality Assurance for Aseptic CMO's - Søborg, Danmark - Novo Nordisk A/S
Beskrivelse
Global Contract Manufacturing (GCM) Quality Assurance (QA) is responsible for quality assurance and quality support for outsourced production activities worldwide. We are looking for a QA professional like you, with a high level of dedication, communication skills and quality mindset. Are you ready to engage, support and collaborate with colleagues in an international business environment, where we both have collaboration internal and with CMO's?
Then you could be our new colleague in GCM QA, located in Østmarken, Søborg (Please note that our department will be relocating to new office buildings in Taastrup by the end of
The position
Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support for outsourced production activities worldwide. You will have the opportunity to make a difference for thousands of patients around the world by ensuring a high level of quality of the products of Novo Nordisk.
As QA Professional you will be responsible for:
• Ensuring quality assurance of contract manufacturing for aseptic CMO's producing drug products (DP).
• Providing support and guidance to stakeholders and CMO's.
• Reviewing batch documentation, final release, and approving changes and deviations for aseptic drug products from CMO's as a key task.
• Engaging in frequent interactions with internal and external business partners, involving a high level of complexity in daily tasks.
• Overseeing daily QA activities typically conducted by contract manufacturers, as well as managing documentation from contract manufacturers and the release of batches from Novo Nordisk.
Since the manufacturers are located outside Denmark, you are expected to travel 5-15 days a year.
Qualifications
To succeed in this role, you should:
• Hold an academic degree in Pharmacy, Biology, Veterinary Science, or a related field.
• Possess a minimum of 3 years of experience in a pharmaceutical organization.
• Demonstrate a solid and up-to-date understanding of quality and GMP requirements, including handling of Deviations (DV), Corrective and Preventive Actions (CAPA), change control, complaints, Annual Product Review (APR), and validations.
• Ideally, be a Qualified Person delegate (QPd) and/or have extensive knowledge of aseptic production or experience working as a QA for CMOs.
As a person, you possess strong cooperation and communication skills, and you are capable of organizing and driving tasks. You exhibit a pragmatic approach to problem-solving, along with strong interpersonal skills. You are detail-oriented with a strong focus on quality, and demonstrate the ability to work both as a team player and independently. You excel in working across departments within an international organization.
About the department
GCM QA is a dynamic department consisting of 50 competent people and is characterized by a high level of professionalism, flexibility, and collaboration. The primary role of our department is to deliver QA support and set direction for our Global Contract Manufacturer Organizations worldwide. The open position as QA Professional is in the GCM QA Operations Drug Product Aseptic team, which is responsible for aseptic production at the CMO ́s.
