Mette Pedersen Email & Phone Number

North Denmark Region, Denmark

Region Nordjylland

North Jutland, Denmark

Northern Region, Denmark

www.mdpedersen.dk

• Main responsibilities:
• Ensure competent resources for qualification of production machines and validation activities (Software validation, FAT/SAT, IQ, OQ & PQ) in Commissioning project portfolio and Pilot/Ramp Up at Thisted site
• Create contracts with external resources per Coloplast procurement guidelines
• Train internal and external stakeholders in qualification, validation- and quality procedures
• Technical approver of Software, FAT/SAT, IQ, OQ & PQ protocols & reports
• Internal Lead auditor (Quality)

• Main responsibilities:
• Process validation (IQ, OQ & PQ) for new machines and revalidation of existing machines including planning, writing of protocols, execution, handling of deviations and reporting
• Design of Experiments (DoE): process optimization & process parameters using sas.jmp as tool for statistical analysis
• Clean zone validation per ISO Class 7 & 8 (e.g air pressure difference, Integrity testing, visual inspection, particle contamination, microbial contamination, supply air volume and no. of air changes, smoke test and.
• Technical approver of FAT/SAT and validation protocols and reports
• Train employees/stakeholders in FAT/SAT, process validation and clean room behavior

• Main responsibilities:
• Write and implement product quality compliance documents in development projects (e.g test methods, quality- and control plans, List of Defects, Visual Acceptance Criteria and Training records)
• Release and disposition of non-conforming products
• Internal Lead auditor (Quality)
• Monitor quality levels and support daily production with quality issues
• Quality task holder and participant in CAPA, Change requests and root cause analyzes

• Main responsibilities:
• Update and maintain Tican`s QMS (Thisted, Fjerritslev and Ansager) with procedures, PRP (pre-requisite programs), OPRP and ensure compliance with legislation and standards (e.g HACCP, ISO22000, BRC and approved.
• Participate in and follow up on deviations and GAPs from third-party audits, veterinary supervision and FDA audits
• Internal auditor
• Introduction courses for new employees in production (Hygiene & QMS)
• Handling of customer complaints and one point of contact for Mortalin (pest control)

• Main responsibilities:
• Microbiological and chemical analyzes of raw – and finished products (e. g Salmonella, E. coli, Staph. Aureus, Listeria ssp. and monocytogenes, proteins, fat, water, salt & nitrite)
• Stability studies of products
• Super user of Sherlock (LIMS)
• Control of cleaning before start of production including planning of sampling, visual and microbiological evaluation
• Ad hoc tasks on the laboratory like purchase of lab equipment, prepare growth mediums, monitor temperature controllers for cold rooms and heating cabinets Results:

Education record

Education record

Education record

Project: “Implementing soft backstop on contour weld” with purpose of reducing use of materials, less stop time and less waste Result.

Education record

Education record

Education record

Education record

Education record

Education record

Internship: ⦁ Geological Institute, Aarhus University ⦁ Including a geologic module “Laboratory course”.

Education record