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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)• Ensure that process risk assessment (mFTA) are conducted for projects • Participate in development and maintenance of Corporate validation procedures Results:• Managed a team of 10 internal and external validation specialists to reach all milestones for Software validation, FAT/SAT, IQ, OQ and PQ for 8 new production machines within 8 months• Developed new Software validation training material using GAMP5 approach for new production machines that are now implemented in QMS and used to train and guide internal and external stakeholders • Trained 4 external machine suppliers in software validation and FAT/SAT ensuring machine suppliers could fulfill Coloplast`s requirements without delays in the respective projects

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 bio-burden sampling)• Technical approver of FAT/SAT and validation protocols and reports• Train employees/stakeholders in FAT/SAT, process validation and clean room behavior• Internal Lead auditor (Quality)• Participate in constant development and maintenance of Corporate validation procedures and templatesResults:• Validation and maintaining state of validation of a new controlled area fulfilling the requirements of ISO Class 7 & 8 at Thisted site. In total 4 machines were validated in the controlled area. • Key member of ensuring scheduled product launch of a new Ostomy platform involving 6 internal and external validations specialist by performing validation, support and train external validation specialists, knowledge sharing, approval of records and follow up on deviations so all records were timely closed

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• Transfer of Quality set up to Hungarian sites (machine transfer)• Participate in process risk assessment meetings as quality specialist representative Results:• Managed a team of 5 quality control employees performing a two-day quality retraining course of >200 blue collared with the purpose of train and align a common understanding of quality related activities (e.g QMS, product knowledge, process control (SPC), nonconforming products, complaints) in the daily work within 6 months. Questionnaires for all blue collared before and after training showed significant improvement in understanding of quality assurance in daily production• Developed test equipment for testing of urine bags per ISO 8669-2 (Urine collection bags -- Part 2: Requirements and test methods) that is used on a laboratory on a Hungarian production site

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 “Egenkontrol”)• 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)• Super user of Sherlock (LIMS)• HACCP team memberResults:• Together with Quality Manager we established a formal Quality department at Thisted site and build up the QMS to achieve Tican’s first BRC certificate and first FDA audit with only minor observations

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:• Updated and standardized procedures and work instructions of the laboratory per ISO17025 (General requirements for the competence of testing and calibration laboratories) • Prepare HACCP documentation and participate in HACCP meetings