Validation Specialist
CurrentConsulting services to the pharmaceutical industry within qualification and validation.
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@bavarian-nordic.com
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Nynne M. Forchhammer is listed as Validation Specialist at QV-Compliance A/S, a with 14 employees, based in Copenhagen, Capital Region of Denmark, Denmark. AeroLeads shows a work email signal at bavarian-nordic.com and a matched LinkedIn profile for Nynne M. Forchhammer.
Nynne M. Forchhammer previously worked as Process specialist - Environmental Monitoring at Bavarian Nordic and Environmental Monitoring Professional at Novo Nordisk. Nynne M. Forchhammer holds M.S., Molecular Biology, Chemistry from Syddansk Universitet - University Of Southern Denmark.
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I have been working with cGMP since 2004, in drug product production, drug substance production, and aseptic production. I have experience from production, support, and QA departments. Since 2011 my focus has been on contamination control of clean rooms, and aseptic GMP.I thrive in a role, where I can use my knowledge of GMP and the SOPs to facilitate compliance. I am aware of the importance of finding solutions, which are not only compliant but also make sense from a business perspective.Delivering training is an activity I appreciate - both as one-on-one training, and class room training in environmental monitoring related topics and GMPI have extensive experience with audits and inspections. Both as participant in facility tours, presenter of data and in the “back-stage” area.Key competences:Aseptic GMP | Environmental monitoring | SOP | Deviation handling | Qualification of HVAC and clean rooms | Lyophilisation | Process understanding (in GMO)Personal characteristics:Strong quality mindset | Analytical | Dedicated | Systematic | Fast learner | Positive attitude
Listed skills include Gmp, Change Control, Sop, Quality Assurance, and 8 others.
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Denmark
Consulting services to the pharmaceutical industry within qualification and validation.
Kvistgård
Implementation and validation of environmental monitoring in Fill and Finish plant from construction (included clean room design and HVAC specifications) to operation.Aseptic GMP - Isolator technology - BSL regulation (level 2).Implemented procedure for risk based set-up of environmental monitoring.Monitoring of regulatory guidelines for updates and new relevant documents.
Im1; Kalundborg
Non-sterile biological API production:- GMP requirements- Qualification of clean rooms- Environmental monitoring- Requalification of HVAC supply to clean rooms- Gowning- Cleaning of facilities- Risk assessment regarding cross contamination
Hillerød
Review and approval of documentation (batch records, deviations and SOPs) related to aseptic production of insulin products.Delegated QP for release of aseptically produced insulin products.
Im1; Kalundborg
GMP and ISO 9001:2000 compliance - support purification departments management team.Inspection and audits - coordination with QA and management, staffing secretariat during, follow-upFacilitate understanding between QA and productionDeviation handling - including implementing new procedure, and writing the departments deviation trend report.Quality Management Review - preparation of, and participation in QMR for IM1.Responsible for the departments Quality Activity Plan
Im1; Kalundborg
Review of documentation related to purification of insulin.Deviations, SOPs, change requests.Lyophilisation.Qualification of re-processing.Control charts for QC analysis during purification process.
Assay development, protein purification, metabolic pathway engineerig
Other employees you can reach at qv-compliance.dk. View company contacts for 14 employees →
Signe Engelsholm
Colleague at Qv-Compliance A/SCopenhagen Metropolitan Area, Denmark
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LM
Lasse Menov
Colleague at Qv-Compliance A/SOdense, Region Of Southern Denmark, Denmark
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MA
Morgana Alecrim
Colleague at Qv-Compliance A/SCopenhagen, Capital Region Of Denmark, Denmark
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Lise Yde
Colleague at Qv-Compliance A/SRegion Zealand, Denmark
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Martin Skarnes
Colleague at Qv-Compliance A/SDenmark
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JB
Jesper Bork Bertelsen
Colleague at Qv-Compliance A/SSlagelse, Region Zealand, Denmark
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Stefano Cignitti
Colleague at Qv-Compliance A/SDenmark
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Signe Hagemann
Colleague at Qv-Compliance A/SCopenhagen, Capital Region Of Denmark, Denmark
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TK
Trine Krab Larsen
Colleague at Qv-Compliance A/SDenmark
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Quick answers generated from the profile data available on this page.
Nynne M. Forchhammer works for QV-Compliance A/S.
Nynne M. Forchhammer is listed as Validation Specialist at QV-Compliance A/S.
AeroLeads has found 1 work email signal at @bavarian-nordic.com for Nynne M. Forchhammer at QV-Compliance A/S.
Nynne M. Forchhammer is based in Copenhagen, Capital Region of Denmark, Denmark while working with QV-Compliance A/S.
Nynne M. Forchhammer has worked for Qv-Compliance A/S, Bavarian Nordic, Novo Nordisk, Novo Nordisk A/S, and Genencor International, Inc..
Nynne M. Forchhammer's colleagues at QV-Compliance A/S include Signe Engelsholm, Lasse Menov, Morgana Alecrim, Lise Yde, and Martin Skarnes.
You can use AeroLeads to view verified contact signals for Nynne M. Forchhammer at QV-Compliance A/S, including work email, phone, and LinkedIn data when available.
Nynne M. Forchhammer holds M.S., Molecular Biology, Chemistry from Syddansk Universitet - University Of Southern Denmark.
Nynne M. Forchhammer is listed with skills including Gmp, Change Control, Sop, Quality Assurance, Protein Purification, Purification, Chromatography, and Protein Chemistry.
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