Sean Waters Email & Phone Number

Solna, Stockholm County, Sweden

Solna, Sweden

Sodertalje, Sweden

Review and approval of SOPs, deviations, change control, analytical procedures, specifications, certificates, study protocols and reports.QC specialist in deviation investigations.QC approval of clinical trial material.

Södertälje

Quality Control responsibility for analytical procedures, specifications, certificates, OOS investigations, deviations, change control, study protocols and reports, environmental monitoring, media (WFI, etc.), GMP materials.Participation in audits and regulatory agency inspections.Resource planning and staff training.

Södertalje, Sweden

Delivery leader in a Contract Development and Manufacturing Organisation, representative of the analytical team in customer projects.Shared responsibility for the quality system.Preparation of GMP documents, e.g. SOPs, specifications, validation documentation, stability protocols and reports.Coordinator of stability studiesResponsibility for OOS investigations.

Södertälje, Sweden

Participation in the set-up and maintenance of a GMP-qualified analytical laboratory. Instrument qualification and management of computerized laboratory systems.Development and validation of analytical methods for process analysis and quality control. Responsibility for drug substance and drug product specifications, stability studies, characterisation and comparability of drug substance.Project Responsible Analyst in a CMC team. Experience of GLP; roles as Principal Investigator and Responsible Scientist in toxicological studies.Outsourcing, CRO and CMO contacts, tech transfer.Interaction with regulatory authorities.

Mölndal, Sweden

Responsibility for analytical development in a tripartite international project aimed at development of a vaccine. Development and validation of analytical procedures.