Validation and Qualification Chemist for Laboratory Automation Development
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Hørsholm
ALK is on an ambitious journey to become the preferred allergy company globally and this is why we are looking for a new colleague to join us.
The position
Do you have an interest in working with qualification of modern analytical instruments and computerized systems validation? Do you have flair for learning new software programs and would you like to be part of a team that develops automation processes and qualify instruments and software for our laboratories in Denmark and abroad?
Then you could be our new colleague in Laboratory Automation Development.
It is our responsibility in Laboratory Automation Development to qualify, implement and manage analytical computerized systems within QC and CMC, ensuring that these systems are fit for intended use and meet the regulatory requirements for data integrity. This is done in cooperation with the end-users as well as with QA, IT and those responsible for the analytical method.
The ideal candidate has experience working with qualification or validation within GMP regulated areas in the pharma industry. However, general experience with equipment, instruments and software programs are also considered advantageous.
Fields of responsibility
You will be working with qualification of instruments and equipment as well as validation of computerized systems (CSV). This requires writing qualification documentation and executing qualification tests in cooperation with the end users.
After implementation of the analytical systems in our laboratories you will be administrating the analytical software and perform periodic reviews and disaster recovery tests. You will be responsible for ensuring data integrity on the systems and participate in implementation projects that require good communication with stakeholders.
Your qualifications
Personally, you are passionate about your assignments. You are team oriented, have a positive attitude and you thrive in an informal work environment.
The department/team
Laboratory Automation Development consists of 7 passionate colleagues. We always try to develop our competences and processes in order to the meet the needs of the patients and all stakeholders, internally as well as externally. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with colleagues.
Laboratory Automation Development work closely together with Analytical departments in CMC, IT, QA and our QC Laboratories mainly in Denmark but also abroad.
The position is located at the ALK headquarter in Hørsholm and it is necessary to live in an area where it is possible to commute daily to the office.
Allergy Solutions For Life
More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing.
By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.
We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
If this sounds like a mission you would like to be part of, we hope to receive your CV and application no later than January 25th 2021.
Job interviews will be held on an ongoing basis.
Contact
For further information on the position please contact Manager Tejs Kyhl, phone no. +45 22 88 17 14.
The position
Do you have an interest in working with qualification of modern analytical instruments and computerized systems validation? Do you have flair for learning new software programs and would you like to be part of a team that develops automation processes and qualify instruments and software for our laboratories in Denmark and abroad?
Then you could be our new colleague in Laboratory Automation Development.
It is our responsibility in Laboratory Automation Development to qualify, implement and manage analytical computerized systems within QC and CMC, ensuring that these systems are fit for intended use and meet the regulatory requirements for data integrity. This is done in cooperation with the end-users as well as with QA, IT and those responsible for the analytical method.
The ideal candidate has experience working with qualification or validation within GMP regulated areas in the pharma industry. However, general experience with equipment, instruments and software programs are also considered advantageous.
Fields of responsibility
You will be working with qualification of instruments and equipment as well as validation of computerized systems (CSV). This requires writing qualification documentation and executing qualification tests in cooperation with the end users.
After implementation of the analytical systems in our laboratories you will be administrating the analytical software and perform periodic reviews and disaster recovery tests. You will be responsible for ensuring data integrity on the systems and participate in implementation projects that require good communication with stakeholders.
Your qualifications
- You have an education as Bachelor of Engineering, cand.polyt, cand.scient., cand.pharm. or similar
- You have knowledge of analytical instruments within the pharmaceutical industry and experience with GMP
- You preferably have experience with computerized system validation and/or equipment qualification
- You have project experience either from handling small to medium complex projects or from participation in projects
- You have a basic understanding of analytical methods
- You have good collaboration and communication skills
- You are fluent in spoken and written Danish and English.
Personally, you are passionate about your assignments. You are team oriented, have a positive attitude and you thrive in an informal work environment.
The department/team
Laboratory Automation Development consists of 7 passionate colleagues. We always try to develop our competences and processes in order to the meet the needs of the patients and all stakeholders, internally as well as externally. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with colleagues.
Laboratory Automation Development work closely together with Analytical departments in CMC, IT, QA and our QC Laboratories mainly in Denmark but also abroad.
The position is located at the ALK headquarter in Hørsholm and it is necessary to live in an area where it is possible to commute daily to the office.
Allergy Solutions For Life
More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing.
By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.
We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
If this sounds like a mission you would like to be part of, we hope to receive your CV and application no later than January 25th 2021.
Job interviews will be held on an ongoing basis.
Contact
For further information on the position please contact Manager Tejs Kyhl, phone no. +45 22 88 17 14.
Information og data
Denne ledige stilling har jobtypen "Laborant", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 4.3.2020, 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.
- Laborant
- Hørsholm
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