Thomas Andersen Email & Phone Number

Allerød, Hovedstaden, Danmark

Roskilde, Sjælland, Danmark

Responsible for 3 departments under QA/QC which involves the QC department, the release department, and visual control department. Key responsibilities:Manage, coach, and develop the QC team ( 8 technician and 2 scientific supporters) in accordance with good laboratory practices Set-up a final release department and ensure that the procedures are implemented in the organisation. Focus has been the regulated products to ensure compliance to meet FDA demands.Handle the In-process… Show more Responsible for 3 departments under QA/QC which involves the QC department, the release department, and visual control department. Key responsibilities:Manage, coach, and develop the QC team ( 8 technician and 2 scientific supporters) in accordance with good laboratory practices Set-up a final release department and ensure that the procedures are implemented in the organisation. Focus has been the regulated products to ensure compliance to meet FDA demands.Handle the In-process control department ( 11 technicians and a team leader) which visuel inspection the +800 products produced at the site. The department is working 24/7 in shifts of 3Responsible for obtaining compliance in audits with support from SME’s in the 3 departmentsDaily reporting to production and upper management. Weekly department meetings and monthly 1:1 meetings if necessary with direct reportsWorking under GMP and ISO 13485The to go person in respect to technical application issuesResponsible for validation of test methods, production environment, shelf-life, software etc. in cooperation with QA and and SME’s in own departments Show less

Roskilde, Sjælland, Danmark

Responsible for the performance release of +800 products for the Life Science, Diagnostic, Vaccine, and IVF market. This involves medical devices Class II and I products. Key responsibilities:Budget responsibleManage, coach, and develop the QC team (8 technician and 2 scientific supporters) in accordance with good laboratory practicesDeploy resources to ensure testing and release of products, handling of OOS in a Trackwise IT system, and follow-up to ensure continuity of… Show more Responsible for the performance release of +800 products for the Life Science, Diagnostic, Vaccine, and IVF market. This involves medical devices Class II and I products. Key responsibilities:Budget responsibleManage, coach, and develop the QC team (8 technician and 2 scientific supporters) in accordance with good laboratory practicesDeploy resources to ensure testing and release of products, handling of OOS in a Trackwise IT system, and follow-up to ensure continuity of servicePromote continuous improvement within the department and provide support other departments in improvement activities Provide training, coaching and support to staff in activities relating to analytical techniques (e.g. ELISA, FT-IR, endotoxin test, RNase/DNase test, bio burden test etc..), company quality systems,GMP and company proceduresSet department objectives/KPI’s and review and assess ongoing performance of direct reportsIn relation to irradiation sterilisation process of medical devices to ensure compliance with regulatory requirements and standards - ISO 11137 and ISO 11737Compliance with ISO 13485 Show less

Roskilde, Sjælland, Danmark

Responsible for the World marker for diagnostic products with the aim to provide application support to the DXPK product portfolio. This involves ELISA and proper plastic bottle selection. Further, conduct technical seminars for sales force and end-users. Key person in respect to complaints which are application driven including investigation and root-cause analysis. Develop Marcom tools, scientific literature together with PM, Marcom and RD. Support of QA and QC during audits.

Roskilde, Sjælland, Danmark

Responsible for the European and Asian technical support of Nunc and Nalgene brand products

Msc, Chemical, Biology

Hd 1. Del

Education record