Tilde Lea Sigaard Email & Phone Number | In my current position I work with Quality Assurance related to the compliant operations of solid dosage forms facilities -Oversee and verify cGMP compliance in the facility, production equipment, utilities, HVAC and processes. -Provide sparring and guidance on cGMP compliance and fulfilment of internal and external requirements. -Review and approval of documents such as instructions, qualification and validation documents, maintenance, calibration, deviations and change requests. -Contamination control strategy in solid dosage forms facilities. -Risk assessments on environmental monitoring and cross contamination In former positions: -Process validation in aseptic production. Compliance with 21 CFR part 210 and 211. -Commissioning and qualification of GMP equipment. -Immunodiagnostic assays and protein chemistry: Experience with multi analyt immunoassays (Luminex), mammal cell growth, transfection of mammal cells, affinity chromatography for protein purification and validation of ELISA (enzyme-linked immunosorbent assay). -Medical Device - Quality agreements, quality specifications and validation documentation: Quality agreements with suppliers of components and modules and quality specifications for receiving inspection, review of design verification test protocols and module specification protocols and reports. Review and support of supplier validation documentation. Statistical sampling plans, Cpk-analysis and supplier visits. Compliance with 21 CFR part 820. -Specialties: GMP, validation

Tilde Lea Sigaard

In my current position I work with Quality Assurance related to the compliant operations of solid do...
Copenhagen, Copenhagen, Denmark

*50 free lookup(s) per month.

No credit card required.

Tilde Lea Sigaard’s Email sigaardt@novonordisk.com

Tilde Lea Sigaard’s Phone Numbers

Get TILDE’s Phone Number (For Free)

Social Media

Tilde Lea Sigaard’s Location Copenhagen, Copenhagen, Denmark

Tilde Lea Sigaard’s Current Industry Novo Nordisk

Tilde Lea Sigaard’s Prior Industry Nne Pharmaplan | Clinical Research Center Hvidovre Hospital | Stanford University

Not the Tilde Lea Sigaard you were looking for?

Find accurate emails & phone numbers for over 700M professionals.

Work Experience

Novo Nordisk

QA Professional

2017-01-01 00:00:00 - Present

Nne Pharmaplan

GMP Specialist

2008-09-01 00:00:00 - 2014-07-01 00:00:00

Clinical Research Center Hvidovre Hospital

Research assistant

2008-02-01 00:00:00 - 2008-08-01 00:00:00

Stanford University

Visiting Researcher

2005-10-01 00:00:00 - 2005-12-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Tilde Lea Sigaard

Tilde Lea Sigaard is located at
Copenhagen, Copenhagen, Denmark

Tilde Lea Sigaard is a In my current position I work with Quality Assurance related to the compliant operations of solid dosage forms facilities -Oversee and verify cGMP compliance in the facility, production equipment, utilities, HVAC and processes. -Provide sparring and guidance on cGMP compliance and fulfilment of internal and external requirements. -Review and approval of documents such as instructions, qualification and validation documents, maintenance, calibration, deviations and change requests. -Contamination control strategy in solid dosage forms facilities. -Risk assessments on environmental monitoring and cross contamination In former positions: -Process validation in aseptic production. Compliance with 21 CFR part 210 and 211. -Commissioning and qualification of GMP equipment. -Immunodiagnostic assays and protein chemistry: Experience with multi analyt immunoassays (Luminex), mammal cell growth, transfection of mammal cells, affinity chromatography for protein purification and validation of ELISA (enzyme-linked immunosorbent assay). -Medical Device - Quality agreements, quality specifications and validation documentation: Quality agreements with suppliers of components and modules and quality specifications for receiving inspection, review of design verification test protocols and module specification protocols and reports. Review and support of supplier validation documentation. Statistical sampling plans, Cpk-analysis and supplier visits. Compliance with 21 CFR part 820. -Specialties: GMP, validation

Tilde Lea Sigaard currently works in the Novo Nordisk |

No Languages Available

Tilde Lea Sigaard has prior
experience in the following industries:
Nne Pharmaplan | Clinical Research Center Hvidovre Hospital | Stanford University

Tilde Lea Sigaard has the following professional experience:
Novo Nordisk | Nne Pharmaplan | Clinical Research Center Hvidovre Hospital | Stanford University