QA Manager
Join Our Team as a QA Manager
We are looking for a full time Quality Assurance Manager to join and strengthen the GMP Operations team at Anocca.
The GMP operations team currently consist of a production team, a QC team, QA managers including QP, facility manager, validation and project managers, for a total of 20 colleagues.
You will be involved in the quality assurance of all operative activities, including document approval, deviation investigations, material release, training of employees, validation of equipment, maintenance of the Quality Management System (QMS) and validation of methods for release of ATMP products, to be used in clinical trials. Also, document administration will be an important part of this role.
Prior experience of working in a GMP environment, either in close collaboration with Quality Assurance departments or within Quality Assurance, is required for this role.
Experience in regulatory guidelines for ATMP (EudraLex Vol.4), aseptic work (EudraLex Annex 1) or in microbiology would be a significant asset.
You must be capable of working as part of a team and as the company and team is very international and the business language is English, excellent English communication skills both in speech and in writing is required.
The role is suited to motivated persons with a drive to learn and grow in a complex and varied environment.
What we are looking for:
• BSc or MSc in life science subject (biology, pharmacy, chemistry or similar)
• Experience working according to GMP
• Meticulous documentation administration skills
• Experienced in deviation investigations, CC and CAPAs
• Fluent written and spoken English
We offer:
An international workplace with plenty of variety in the job, interaction with all other Anocca employees and the opportunity to work at the exciting intersection of biotechnology and medicine.
Compensation:
• Monthly salary
• Tier 1 occupational pension plan
• Wellness grant
• Flexible work hours
How to Apply:
If this QA position resonates with you, we would love to hear from you. Submit your application, including your CV and a cover letter, through our careers portal. Join us in making a difference, apply now!
We ensure unbiased recruitment by hiding your personal information such as name, email, etc. and photos from the recruiter during the screening process.
- Department
- GMP and Production
- Locations
- Södertälje, R&D & Manufacturing
- Employment type
- Full-time
- Core
- GMP Operations
About Anocca
An emerging biotech with transformative potential
Anocca is a privately held Swedish biotechnology company founded in 2014 with the mission to establish a unique technology platform for analysis of T-cell biology to unlock the therapeutic potential of T-cell immunity.
Anocca’s technologies enable the highly precise and efficient analysis of T-cell biology required to deliver a range of therapeutics that specifically harness or manipulate T-cell immunity in a number of disease areas. With a focus on delivering TCR-modified T-cell therapies (TCR-T) in oncology, Anocca is rapidly progressing a pipeline of novel T-cell therapies towards clinical trials utilizing our own manufacturing capabilities.
Anocca’s powerful technologies are also being deployed to develop a range of novel therapeutic and prophylactic products in oncology, infectious disease and autoimmunity.
QA Manager
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