...Om jobbet
Job-Link søger en yderst organiseret og detaljeorienteret Quality Controller til at være en del af et professionelt og ambitiøst team hos en af vores Internationale medicinal kunder med lokation i Kalundborg.
I takt med øget produktion og mange store projekter...
...principles, including day-to-day leadership, planning, budget and cost control, and the ability to manage complex installations in medical... ...team selection, and maintaining the quality of tender documents.
Assume day-to-day leadership for contract management projects...
...give input on P&ID, GA and other technical documents.
Preparation of TS/RFQs for various... ....
Preparation of documents as per document list within time frame.
Participate in... ...along with PM.
Work in internal document control system Promis . And partly our ERP...
...Activities include coordination of analytical validations, regulatory documents, submissions to and questions from authorities across the globe... ..., Regulatory Affairs, and representatives from Quality Control departments.
• Collaborate and coordinate with analytical professionals...
...Review and approval of analytical documentation from CMOs and/or testing laboratories,... ...laboratory investigations, OOS, change controls, CAPAs, and stability protocols, reports... ...Analytical Development and/or Quality control.
It is a great advantage if you have...
...need to expand capacity for even stronger quality processing and control. Hence, we are seeking a skilled individual to maintain the... ...in ensuring the highest standards of quality for our client's documentation. You and your team will be responsible for monitoring and rectifying...
...approval of distribution related deviations, CAPAs and change controls
Qualification of customers
Participate and/or perform... ...for the partner collaboration, for i.e., sharing of documents, timely notifications, commitments and for other regulatory obligations...
...want to make a difference in the way we work with compliance documentation, data integrity and test automation in the pharmaceutical industry... ...with IT QA and Compliance to ensure that we remain in control and that the system remains fit for intended use.
Ensure...
...with stakeholders from various fields.
About the department
Our team is part of the BRD Manufacturing Development & Quality Control area that is based in Denmark. What other companies call Manufacturing Science & Analytical Technology (MSAT) we call Manufacturing...
...on work on automated systems? Do you have experience to do problem solving in highly regulated industries? Are you meticulous in documenting activities and taking responsibility for equipment?
Then you might be our new colleague! Read more and apply today for a life-changing...
...manufacturing processes.
-Assisting with implementing code changes, conducting some of the required tests and producing qualification documentation.
-Working in close cooperation with the colleagues from across the production, getting to know exactly why and how things do...
...tager vare på hinanden.
Typiske samarbejdspartnere vil være indkøbskollegaer, projektledere, designledere, ingeniører, projekt controllere, kunder og naturligvis leverandører. Der vil også være berøring med blandt andet tidsplanlæggere, jurister, projektassistenter,...
...background, and interest, you will also take part in non-compartmental PK/PD analysis, interpretation of data, and authoring of regulatory documents.
We are looking for an engaged, detail-oriented, and result-focused colleague who is passionate about bioanalysis and drug...
...phase, your tasks will include implementation of a new maintenance strategy, process optimization, operation optimization, and documentation preparation.
Once the line is fully implemented, your focus will be on:
• Providing technical support to the line, including...
...people for our kitchen team. Your main job will be ice cream production; however, you will also do backing up/postproduction, quality controls, order acceptance and cleaning, as well as help in the shop if needed. To thrive in our kitchen, it is important that you are a...
...previous experience you know how to easily adapt to different industries, business settings and users in your communication style and documentation practice. You are naturally outgoing and enjoy building and maintaining relationships with your users.
Key...
...Collaborate with stakeholders across different functional areas (such as Finance, Sales, Procurement, and HR) to understand and document governance requirements
• Translate business needs into technical specifications for MDG and DQM solutions
• Lead the configuration...
...are not clearly scoped or defined in advance.
About the department
Our team is part of the BRD Manufacturing Development & Quality Control area that has its base in Denmark. What other companies call Manufacturing Science & Analytical Technology (MSAT) we call...
...within quality and compliance and support in daily quality and compliance decisions for tasks in the team.
Writing registration documents required for approval of the product for the marked.
Participation in risk assessment and other workshops to secure high degree...
...in the design and development of funding programmes.
Formulating the content of reports, recommendations, and other written documents clearly and professionally.
Professional and personal qualifications
We are looking for a Scientific Manager with:
Research...
...Er du revisor eller controller på vej mod næste skridt i karrieren? Bliv Senior Consultant i vores CFO Services-team, og udbyg din finansielle værktøjskasse.
Vi søger erfarne financeprofiler, der ønsker at accelerere karrieren som konsulent.
Vi skræddersyr din...
...activities.
Your Background :
~ Minimum 2-4 years of verifiable experience in 800xA DCS programming .
~ Minimum 2-4 years of documented experience in 800xA Batch Management .
~2-4 years of experience in Design (Functions Specification).
~2-4 years of...
...presentations, agendas for meetings, gathering information, data validation, etc.
Support with the development of existing projects
Document and data management
Administrative tasks such as filing, typing, copying, binding, scanning
Monthly Reporting
What we...
...Hvad har du med i bagagen?
Måske kommer du allerede fra konsulentbranchen eller sidder internt i en finansfunktion som fx controller og synes, det er sjovt at sætte strøm til processer og lege med IT. Hvor end du kommer fra, så er det vigtigste, at du har aspirationer...
...You will be responsible for:
Drive shipping validation activities and projects.
Generate shipping validation relevant documentation (URS, Protocols, Reports etc.)
Collaborate with cross-functional teams to develop and implement validation plans.
Lead...
...the following:
• Define and optimize the technical infrastructure for SAP systems within the STG landscape.
• Develop and document the SAP Environment strategy, encompassing client strategy, transport management, and assessment of SAP sizing.
• Facilitate seamless...
...will take part in securing our supply of commercial manufactured drug products. Moreover, you will take part in consolidating and documenting the validated state.
The position reports to the director of Drug Product Manufacturing and the candidate will be a part of a...
...across Novo Nordisk, such as a Production team, Production Support Team, IT, Automation and Robotics team, Quality Assurance or Quality Control, Business Support Team.
We encourage you to read more detailed information about the different roles and areas through this link...
...plants across various industries, focusing on medium to high complexity projects.
Technical Documentation: Prepare technical specifications and other project-related documents.
Technical Calculations: Perform technical calculations and verifications as part of...
...thrive and are developed to maintain a high scientific level in drug product manufacturing
Involved in writing regulatory documentation for BLA/NDA/MAA and main responsible for filing in all other markets for drug product
Involved in scientific documentation...