With a solid background in regulated industries – such as life science and the fertility industry, I have a long-standing experience working with product quality, patient/consumer safety, information security, legal requirements and compliance.
From 2012 on, I acted as the Quality Manager/Responsible Person in an innovative and fast-growing company within the fertility industry. Over the next eight years, I documented all business processes, and shaped the company quality/privacy framework, through the development, implementation and maintenance of a quality management system (modelled on ISO 900X, EU/GxP etc.), and later – in my capacity as DPO/GDPR Specialist, a full GDPR compliance-package (modelled on ISO 2700X/27701/27799/29100).
Quality Management helps an organization achieve greater consistency in tasks and activities, involved in the production of products and services. It increases efficiency in processes, reduces wastage, and improves the use of time and other resources. It enables an organization to market their business effectively, exploit new markets and to continuously improve their products, processes, and systems.
At its core, quality management is a business philosophy that champions the idea, that the long-term success of a company comes from customer satisfaction and loyalty. An approach I very much agree with.
I am used to ensuring quality, efficiency and safety in all phases of a product’s or service’ supply chain/life cycle, and I take pride in promoting a culture, that delivers value by fulfilling the needs and expectations of customers and other interested parties.
With a commercial mindset, a passion for creating the best possible product and user experience, and an understanding of the importance of having a 360-degree overview of the challenges and opportunities affecting compliance levels and the client, LHR Consult offers the following services:
- Providing professional expertise and guidance on quality planning, quality assurance, quality control and quality improvement (EU/GxP, ICH, WHO, ISO 900X etc.).
- Acting as Quality Responsible/subject-matter expert.
- Mapping of data/dataflows, systems, processes, responsibilities, quality, risks, controls and indicators.
- Planning, implementing and driving the processes of risk management, including identification, performing qualitative/quantitative analyses and risk reports, monitoring and controlling – and proactively developing risk mitigation actions (EU/GxP, ICH, ISO 27005/31000).
- Preparing, implementing, operating and continually improving quality management systems/documentation within all aspects of regulatory compliance, e.g. contingency plan, quality manual, policies and SOPs (EU/GxP, ICH, WHO, ISO 900X etc.).
- Setting up and driving electronic document management systems (EDMS) for managing the creation, organizing, filing and accessing, using, sharing, controlling and securing etc. of company documents.
- Determining, measuring, analyzing, evaluating and monitoring of metrics and key/quality indicators (KPIs) to demonstrate performance.
- Management of integrated business processes across the supply chain (supply chain management).
- Identifying and managing challenges and opportunities incl. optimizing of processes/systems (digitation/automation, integration of controls etc.).
- Ensuring that changes to products, processes and systems are introduced in a controlled and coordinated manner (“change control”).
- Preparing training programs and providing stakeholders with the required training- and awareness activities etc.
- Preparing, executing and hosting of – and follow up on internal/external/”supplier” audits and government inspections, consolidating compliance with legal/internal requirements (IAASB, ISO 19011/27007).
- Registrating, assessing and reporting of unintended incidents, adverse reactions, deviations, non-conformities, complaints, claims etc. – incl. root cause analysis, establishing, implementing and evaluating the effect of and corrective/preventive actions (CAPA), trend analysis etc. (e.g. EU/GxP).
- Preparing, concluding and maintaining of third party agreements/contract management (customers, vendors, affiliates, partners etc.).
- Coordinating/performing recall operations, disposal and returns to saleable stock.
- Providing expertise and guidance on laboratory safety and precautionary measures, e.g. regarding clean room use, air quality (particle/microbial counts etc.), aseptic/sterile production, personal protective equipment, test kits/methods/results, biohazardous waste, liquid nitrogen/gas alert detectors, blood sampling, cleaning, hygiene and sanitation etc. (EU/GxP, OECD, WHO etc.).
- Calibrating, qualifying, monitoring and maintenance of laboratory/cryogenic equipment incl. reviewing and assessing of validation-, service- and inspection reports, certificates of analysis, package inserts, user manuals, accreditations, technical specifications etc. (EU/GxP, OECD, WHO).
- Preparing of other corporate/staff documentation (e.g. code of conduct/ethics, terms & conditions, confidentiality agreement, staff handbook, job description and introduction plan).
- Facilitation of change processes from idea to concept (design thinking, user involvement, etc.).
- Providing professional expertise and guidance on health-/drug law, best practice/guidelines, standards etc. (e.g. DPSA, DMA, HFEA, BGV, EU/GxP, ICH, FDA/21 CFR, WHO, ISO).
- Liaising with regulatory authorities – related to registrations, applications, reporting, legal requirements etc. (e.g. DPSA, DMA, SSI, NVK).