We are looking for a contractor to fill the role of Lead Investigator Scientist for the Manufacturing Science & Technology department of a global pharmaceutical company.
Our client is a global biopharmaceutical company located near Neuchatel, Switzerland
Focused on R&D and delivery of innovative medicines across several therapeutic areas, including oncology, haematology, immunology, and CVD.
MS&T is a science-driven organization dedicated to building in-depth and comprehensive knowledge of the client's OSD products and processes. They work across the entire lifecycle of their pharmaceutical products, supporting the manufacturing site.
The Lead Investigator is accountable for conducting deviation investigations until conclusion within the standard scrutiny of governing compliance bodies supporting the Global Investigation Program. The scope of investigations relates to all types of manufacturing processes, such as bulk production, packaging operations, warehousing & supply, and technical services.
The Lead Investigator’s main activities are completed autonomously for the following tasks and responsibilities:
Facilitate triage of deviations to assist deviation owners in defining the need for investigations.
Supports initial impact/risk assessment for all deviations in conjunction with Quality Operations.
Lead and conduct investigations until the conclusion and ensure that the investigation outcome, root cause analysis and execution of corrective and preventive actions are completed in a timely, effective, and compliant manner. The investigation scope may be related to bulk operations, packaging operations, warehouse, or maintenance processes.
Partner with quality assurance and impacted departments (production, quality control, warehouse, maintenance, etc.) to ensure investigations are exhaustive.
Provide appropriate level of reporting and communication on the assigned investigations, at site and global levels (Investigation Review Board, pharma MS&T reporting).
Share good practices within the site and with other sites.
Perform complaint investigations.
Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team, and proposing solutions.
Participate in or lead projects and initiatives within MS&T team.
Provide support to other MS&T teams (such as robustness, qualification, .) as required
Our client is looking for someone who has:
BS/MS in Engineering/Technical discipline or equivalent experience
At least 5-8 years’ experience in pharmaceutical operations, validation, quality assurance, packaging, or related field, if possible Oral Solid Dosage manufacturing
Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.).
Well-developed ability to constructively work across functional areas and levels to achieve results,
Technical writing skills,
Strong communication skills,
Strong analytical, problem-solving, influential, and deductive skills,
Capability to work with short deadlines and simultaneous activities,
Excellent organizational and project management skills.
Fluent in English and in French.
Only applicants eligible to work in Switzerland will be considered e.g. Swiss nationals, current Swiss work permit holders or cross-border EU citizens.
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