SWAY Consultants have more than 10+ years of expirience working in regulated environment. This experience provides context and understanding of complex processes and management systems.
Each consultant has held varius positions within:
Having worked in different postions and acuired knowledge of required deliverables enables SWAY consultants specific and targeted efforts with a holistic perspective and cross functinal business understanding.
Sven has been working in the pharmaceutical industry since 2010.
He has held a variety of positions, specialist, manager and project manager. Work approach is structured, systematic and result orientated while maintaining the required quality in the deliverables.
Sven has managed projects in the pharmaceutical industry with high complexity and business impact, and have experience in developing GxP documentation such as deviations, CAPA’s, SOP’s, change control cases and qualification protocols and reports.
In recent years, Sven have also held training courses in deviation management, systematic problem solving and risk assessments.
Cand. Polyt (Biotechnology), DTU, Denmark
Project management (Equipment acquisition, facility changes, Management system implementation, Business optimization and IT projects. Worked with both CAPEX and OPEX.)
Development of GxP Documentation (Qualifications, validations, Deviations, Risk assessments, Change Management, SOP’s etc.)
Quality Management System governance (QMR reporting, developing quality indicators, implementing changes/QMR actions)
Supplier Management (Development of procedures, risk scoring, service level agreements, performing audits and implementing changes at suppliers.)
Biological Risk Management (Defining corporate and local requirements, implementation of risk based decisions and securing containment of biological agents)
Auditing (Certified auditor in ISO9001.)
Jacob has 10+ years of experience within the pharmaceutical and medical device industry. He has held various positions as specialist and manager within QA and QC. Work approach is systematic and holistic with a focus of process output to ensure timely delivery.
Jacob has great experience in establishing and implementing QMS processes, both in a facilitating and executing role. In this, Jacob has succeeded with stakeholder management and process implementation in complex organizations and regulated environments.
Jacob is also an experienced lead auditor with 5+ years of both internal and external auditing (domestic and international). Especially with supplier audits as part of supplier quality management processes (ISO13485/MDSAP, CFR820 and ISO9001) where establishment and negotiation of supplier quality agreements additionally is a great strength with Jacob.
Cand. Polyt (Biotechnology), DTU, Denmark
Business Diploma (B.Sc.) HD Finance, CBS, Copenhagen Business School
Lead auditor (Certified lead auditor in ISO9001 and ISO13485)
Execution of GxP documentation (CAPA, Deviations, CR/CC, SCAR’s, Qualification and Validation documentation)
Facilitating and implmentation of procedures for GxP (Profound user of systematic problem solving, gap analysis and value-stream mapping)
Supplier and CMO Management (Supplier qualification and Supplier life-cycle management)
XXX has been working in the Biotech and Pharmaceutical industry since 2008. She has held various manager positions in production and QC, all with principal decision making. Work approach is structured, systematic and result orientated while maintaining the required quality in the deliverables.
XXX has extensive experience in audits and inspections, leading facility/area tours in production and laboratories as well as presenting documentation for authorities such as FDA and DMA. She has developed GxP documentation such as deviations, CAPA’s, SOP’s, SPEC´s, change control cases, verification and qualification protocols and report. Sarahs has a proven track record in succeeding with process optimization and alignment,- and excelled in her shop floor presence and performing process confirmation.
In more recent years XXX has taken on trainer roles, providing training courses in Microbiology in pharma, Aseptic behavior and Environment, Health and Safety applied in production areas and Laboratories
Cand. Scient. In Parasitology, KVL, Denmark
BSc. In Agricultural Science, KVL, Denmark
Operational optimization (Skillfull planning and execution of operational activities)
Execution of GxP documentation (QMR, Quality metrix, CAPA, Deviations and CR/CC )
Facilitating and implmentation of good aseptic practice (Implementation and consolidation of aspectic practice in production and laboratory facilities)
Root cause investigation (Facilitate and execute root cause incestigation in various tools)
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