Nynne M. Forchhammer Email and Phone Number
Nynne M. Forchhammer work email
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Nynne M. Forchhammer personal email
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
Qv-Compliance A/S
View- Website:
- qv-compliance.dk
- Employees:
- 14
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Validation SpecialistQv-Compliance A/S Jun 2024 - PresentDenmarkConsulting services to the pharmaceutical industry within qualification and validation.
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Process Specialist - Environmental MonitoringBavarian Nordic Jul 2018 - May 2024KvistgårdImplementation 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. -
Environmental Monitoring ProfessionalNovo Nordisk Nov 2011 - Jun 2018Im1; KalundborgNon-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 -
Qa ProfessionalNovo Nordisk A/S May 2010 - Nov 2011HillerødReview 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.
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Quality CoordinatorNovo Nordisk A/S Jun 2006 - Apr 2010Im1; KalundborgGMP 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
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Process SupportNovo Nordisk A/S Oct 2004 - May 2006Im1; KalundborgReview of documentation related to purification of insulin.Deviations, SOPs, change requests.Lyophilisation.Qualification of re-processing.Control charts for QC analysis during purification process.
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Research Assistant/AssociateGenencor International, Inc. Jan 1999 - Jan 2004Assay development, protein purification, metabolic pathway engineerig
Nynne M. Forchhammer Skills
Nynne M. Forchhammer Education Details
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Molecular Biology, Chemistry
Frequently Asked Questions about Nynne M. Forchhammer
What company does Nynne M. Forchhammer work for?
Nynne M. Forchhammer works for Qv-Compliance A/s
What is Nynne M. Forchhammer's role at the current company?
Nynne M. Forchhammer's current role is Aseptic production & GMP | Environmental monitoring | cGMP | Qualification & Validation | Audit & inspections | QA.
What is Nynne M. Forchhammer's email address?
Nynne M. Forchhammer's email address is nf****@****isk.com
What schools did Nynne M. Forchhammer attend?
Nynne M. Forchhammer attended Syddansk Universitet - University Of Southern Denmark.
What skills is Nynne M. Forchhammer known for?
Nynne M. Forchhammer has skills like Gmp, Change Control, Sop, Quality Assurance, Protein Purification, Purification, Chromatography, Protein Chemistry, Aseptic Processing, Lyophilization, Environmental Monitoring, Lean.
Who are Nynne M. Forchhammer's colleagues?
Nynne M. Forchhammer's colleagues are Morgana Alecrim, Lise Yde, Signe Engelsholm, Martin Skarnes, Lasse Menov, Signe Hagemann, Trine Krab Larsen.
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