Quality Assurance Manager

Quality Assurance Manager

Do you want to join a successful international biotech company in Odense, Denmark?

Alphalyse is looking for a dedicated quality assurance manager to ensure quality controlled protein analysis for clinical development of novel protein drugs to service our biopharma clients. The services include advanced mass spectrometry analysis (LC-MS) to support process development and GMP-manufacturing of novel vaccines, monoclonal antibodies, therapeutic proteins, as well as cell and gene therapy products.

Job description

We seek a systematic scientist with a cand. scient, cand. pharm, chemical engineer or similar, with experience in GMP from the pharmaceutical industry and a general interest in quality assurance tasks. You will be responsible for developing and maintaining our quality control system and for guiding our team of protein scientists in improved quality-controlled analysis

Your skills and experience

You must have 2-5 years of experience in an GLP/GMP environment with Quality Control activities.

The successful candidate will have most of the following qualifications:

  • Experience with GMP regulations, audits, and inspections.
  • Knowledge on GMP/GLP regulations for EU and US compliance
  • Experience with analytical method validation according to ICH Guidelines
  • Solution-oriented to support quality of data

Main job functions

  • Responsible for creation and maintenance of Quality and the Pharmaceutical Quality System
  • Implement and use Quality Risk Management principles
  • Review, approval of procedures, instructions, and methods
  • Handling of change controls, deviations and CAPAs for continuous improvement of the Pharmaceutical Quality System
  • Perform internal audits and vendor audits
  • GMP support to colleagues
  • Assuring compliance according to legislation, internal procedures, and customer requirements
  • Support and communication with customers
  • Contact to authorities
  • Host external audit and inspections
  • Review and approve Certificate of Analysis
  • Perform Management Review

As a person, you are a team-player with good collaboration and communication skills in English and Danish. You can work on multiple projects at the same time and have an eagerness to learn and improve. You are service-minded and thrive in a team.

Do you want to join our team?

Please send us your application as soon as possible and no later than November 8, 2020 to Ejvind Mørtz mortz@alphalyse.com. Include a personal letter with motivation, your CV, and relevant diplomas with grades. For more information about the position contact Ejvind Mørtz at +45 6310 6504.

About us

Alphalyse is a Danish contract research laboratory. We use our passion for protein analysis to help clients optimize their development and manufacturing of biopharmaceuticals. Since 2002 we have steadily grown our product range, revenue, and number of employees.

We work with industry leaders for unique access to top-of-the-line equipment, new protein chemistry tools, and to the latest research. Thus, we have developed a unique method for quantification of Host Cell Protein (HCP) – in which we are leading in the world.

Our most important asset is our team of highly skilled scientists, who are experts in characterization of biopharmaceutical proteins. We encourage a work environment that is exciting, challenging and fun. Recently, we moved into new modern facilities close to SDU.

Click here to download job description as pdf

Company
Name
Alphalyse
Same as (Website / Social Media)
Job Location
Street
Rødegårdsvej 209 C
Postal Code
5230
Locality
Odense M
Country ISO Code
DK
Region ISO Code
DK
Salary
Unit
Monthly
Currency ISO Code
Value
0.00
Job Meta
Employment Type
Full Time
Valid Through
08.11.2020

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