Mark Gertz Rosendahl Email & Phone Number

Vejle, Dk

Odense, South Denmark, Denmark

Odense, South Denmark, Denmark

Managing the QA Product Development team while still handling specialist tasks

Odense, South Denmark, Denmark

Odense S, South Denmark, Denmark

Responsible for development of new generic product (tablets, sterile, solutions, inhalation, creams, gels etc.) :-Specifications-Analytical method validation and transfer-Process validation etc.-Approval of audit reports-N-nitrosamines-Elemental impurities-Extractables & Leachables-Assisting and troubleshooting during product/analytical development

Odense S, South Denmark, Denmark

During a one year temporary position I will:-eliminate back logs in PQR (Product Quality Review) and audit reports-assist in method transfer-be involved in selection and implementation of an electronic Quality Management System-share my experience in extractable and leachable studies-handle complaints and deviations

Viby J, Region Midtjylland, Danmark

Handling customer requests regarding questionnaires, MSDS, audits, shelf life evaluation, food safety visas, specifications (SAP), complaints, and deviations on whey and milk powders products for food and feed (GMP+) etc.Acting as a mediator between sales and supply chainProjects related to improvement and new products.

Vejle

-development of a new degradation product method including validation/ruggedness/robustness work-associated Abbreviated New Drug Application (ANDA) documentation-consultant for Fertin R&D India

Vejle

-introduction of new pharmacopeial (USP/Ph. Eur) raw materials including verification/validation and specification related work-development of a new degradation product method including validation/ruggedness/robustness work-associated Abbreviated New Drug Application (ANDA) documentation-consultant for Fertin R&D India

Vejle

Fertin had decided to strengthen their effort in compressed tablet technology. With my internal experience with non-gum analytical development, I was an essential part of that strategy.My key responsibilities were: -introduction of new pharmacopeial (USP/Ph. Eur) raw materials including verification/validation and specification related work-development of a new degradation product method including validation/ruggedness/robustness work-associated Abbreviated New Drug Application… Show more Fertin had decided to strengthen their effort in compressed tablet technology. With my internal experience with non-gum analytical development, I was an essential part of that strategy.My key responsibilities were: -introduction of new pharmacopeial (USP/Ph. Eur) raw materials including verification/validation and specification related work-development of a new degradation product method including validation/ruggedness/robustness work-associated Abbreviated New Drug Application (ANDA) documentation-consultant for Fertin R&D India Show less

Vejle

Developing analytical methods for nicotine non-gum products, radically innovative (pharmaceutical nicotine) products, and raw materials. Products include nicotine containing pharmaceutical non-gum formulations in platforms such as Electronic Nicotine Delivery Systems (ENDS), Pressurised Metered Dose Inhalers (pMDI), Dry Powder Inhalers (DPI), nebulizers, mouth/nasal sprays, thin film strips, patches, oromucosal sprays, drops, soft mist and vapour inhalers, lozenges, etc.Analytical… Show more Developing analytical methods for nicotine non-gum products, radically innovative (pharmaceutical nicotine) products, and raw materials. Products include nicotine containing pharmaceutical non-gum formulations in platforms such as Electronic Nicotine Delivery Systems (ENDS), Pressurised Metered Dose Inhalers (pMDI), Dry Powder Inhalers (DPI), nebulizers, mouth/nasal sprays, thin film strips, patches, oromucosal sprays, drops, soft mist and vapour inhalers, lozenges, etc.Analytical planning, product development, stability, result interpretation and prediction.Trouble shooting. Understanding nicotine degradation in chewing gum formulations. Consultant for Fertin R&D India. Show less

Vejle

Developing analytical methods for nicotine gums.Supporting strategic development in terms of analytical planning, product development, gum base development, API development, result interpretation and prediction, and stability. Trouble shooting. Understanding nicotine degradation in chewing gum and other formulations - resulting in a comprehensive internal report based on scientific literature and experiments. Consultant for Fertin R&D India.

Vojens

Pharmaceutical and dietary supplement products.Approval of raw and packaging materials as well as products for QA to release. Supporting analytical laboratory, validations/qualifications, troubleshooting, method development, AAS, FT-IR, Dissolution Tester, furnace, ovens, HPLC, Karl-Fischer, titrator, optimisations, monograph verifications, external analyses, and acquisition of new equipment.Identification of shortcomings and development of the quality management system (GMP)… Show more Pharmaceutical and dietary supplement products.Approval of raw and packaging materials as well as products for QA to release. Supporting analytical laboratory, validations/qualifications, troubleshooting, method development, AAS, FT-IR, Dissolution Tester, furnace, ovens, HPLC, Karl-Fischer, titrator, optimisations, monograph verifications, external analyses, and acquisition of new equipment.Identification of shortcomings and development of the quality management system (GMP) with e.g. the addition of qualification SOPs.Documentation: Quality control, SOP, Pharmacopeias, revisions, trending, GMP, workplace safety instructions (arbejdspladsbrugsanvisning), Show less

Promotion of the association at Aalborg University by flyers, posters, and e-mails e.g.

Aalborg

I was responsible for introducing high school students to chemical engineering.I also supervised high school students during their subject assignment (studieretningsopgave; tidl. 3. årsopgave).

Skive

Military conscription at the engineer troops at Skive Kaserne in the EOD (Explosive Ordnance Disposal) platoon

Master'S Degree, Chemical Engineering

Activities and Societies: Steering group member (evaluating semesters influencing the courses for next years' students) Analytical.

Stx, Chemistry, Mathmatics, And Physics At A Level (Highest Possible)

Education record