Scientist Lead Investigator, MS&T

Consultants in Science Sàrl; Suisse; Sur place; EUR 96 000 - 129 000; Plein temps

Résumé du poste

A global biopharmaceutical company is seeking a Scientist Lead Investigator to conduct deviation investigations at their manufacturing site in Switzerland. The ideal candidate will have a degree in a technical discipline, fluency in both English and French, and at least 2 years of experience in pharmaceutical operations. The role requires excellent analytical and problem-solving skills, as well as the ability to communicate effectively across departments. Knowledge of compliance and regulatory standards is essential.

Qualifications

• At least 2 years of experience in pharmaceutical operations or related field.
• Fluent in English and in French.
• Knowledge of regulatory regulations and cGxP requirements.

Responsabilités

• Conduct deviations investigations and ensure conclusions are compliant.
• Support initial impact/risk assessment for deviations.
• Lead investigations and ensure corrective actions are executed.
• Collaborate with quality assurance and impacted departments.
• Provide reporting and communication on investigations.

Connaissances

Analytical skills

Problem-solving skills

Technical writing

Organizational skills

Project management

Influential skills

Formation

BS/MS in Engineering/Technical discipline

Description du poste

For our client a global pharmaceutical company, we are looking for a Scientist Lead Investigator, MS&T consultant.

The 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.

The Role

The Lead Investigator is accountable for conducting deviation investigations until conclusion within the standard scrutiny of governing compliance bodies in support with the Global Investigation Program. The scope of investigations relates to all types of manufacturing processes, such as bulk production, packaging operations, warehousing and supply, technical services in Oral Solid Dosage Manufacturing site.

Duties and Responsibilities:

Facilitate triage of deviations to assist deviation owners to define need for investigations.

Supports initial impact/risk assessment for all deviations in conjunction with Quality Operations.

Lead and conduct investigations until conclusion and ensures that the investigation outcome, root cause analysis and execution of corrective and preventive actions are completed in a timely, effective and compliance manner. 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 to or lead projects and initiatives within Boudry MS&T team.

Provide support to other MS&T teams (such as robustness, qualification) as required.

You

Our client is looking for someone who has the following skills, knowledge and qualifications:

Well-developed ability to constructively work across functional areas and levels to achieve results.

Technical writing 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.

BS/MS in Engineering/Technical discipline or equivalent experience.

At least 2 years of experience in pharmaceutical operations, validation, 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.) is a nice to have.

All applicants must be authorised to work in Switzerland and be of Swiss nationality or have a valid Swiss working permit.