Senior Associate, QA LSM Operations

Do you have solid GMP knowledge and some experience working in the pharmaceutical industry? Then we have a great new opportunity for you!

Job Category


Requisition Number


Job Description

We are currently looking for a Quality Professional to join our QA LSM Operations team in Hillerød!

In this role, you will assess drug substance quality through review of solution lot records and batch production records and by being on the floor during manufacturing as applicable. 

You will also maintain the quality system related to the exceptions and disposition processes based on current GMP, GDP and regulatory requirements. 

Primary Responsibilities
- Perform timely QA review and approval of batch documentation for drug substance through assessment of the process parameters, solution lots, and batch production records utilized during batch manufacturing
- Act as primary QA contact for the LSM Compliance team, Manufacturing Management, Engineers, and Manufacturing Associates when investigations are ongoing to resolve deviations and/or CAPAs related to the manufacturing process for drug substance. Including participation in on-line trouble shooting and investigations as needed
- Perform review and approval of documentation, deviations, CAPA etc. in connection to batch disposition
- Participate in execution of audits and inspections from competent authorities and external parties and act as subject matter expert
- Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications


- Solid GMP knowledge and QA and/or manufacturing experience from the pharmaceutical industry
- Work experience or educational background that allows for understanding of the complexity of manufacturing biologics


- Preferably Master of Science, e.g. Pharmacy, Biotechnology, Biology or similar

Employment Category

Full-Time Regular

Experience Level


Du har ikke vedlagt dokumenter til din ansøgning. Klik på 'OK' knappen nedenfor for at sende din ansøgning alligevel, eller klik på knappen "Annuller" og vedhæft dokumenter, før du sender din ansøgning igen.

Ikke det rigtige job?

Opret en jobagent og få dit nye job direkte i indbakken

Opret jobagent her

Andre job der matcher din søgning

QA Professional for Sourcing Operations QA


Are you ready to contribute to ensuring the high quality of Novo Nordisk products? Would you like to cooperate with stakeholders across the Sourcing Supply chain? If so, we can offer a challenging and exciting job opportunity as Quality Assurance (Q...
Indrykket:3. april 2018
Udløbsdato:27. april 2018

Quality Engineer in Devices & Supply Chain Management


Are you ready to realise your scientific potential and Lean knowledge? As Senior Quality Engineer you will carry a great responsibility in our striving towards strengthening Novo Nordisk s position as an innovative pioneer and respected industry lea...
Indrykket:6. april 2018
Udløbsdato:20. april 2018

Associate, Quality Assurance


Are you a recent Graduate with some experience working within the pharmaceutical industry and are you looking for a new opportunity? Then you might be the person we are looking for! Job Category Quality Requisition Number 34393BR Job Description We ...
Indrykket:16. april 2018
Udløbsdato:11. juni 2018

Associate, Quality Control


We are currently looking for a driven and motivated team-player to join our QC Materials team in Hillerød. You will be part of a smaller team of 12 people who is responsible for sampling and testing raw materials and packaging materials. Job Categor...
Indrykket:16. april 2018
Udløbsdato:11. juni 2018

Senior Associate, QA (Supplier Quality), Delegated QP


Are you an experienced Quality Professional with experience working in a dynamic and international environment? Then you might be the person we are looking for! We have an exciting new opportunity for an experienced QA Professional to join our Exter...
Indrykket:16. april 2018
Udløbsdato:11. juni 2018