Contractor Scientist Lead Investigator

Industry: Pharma
Skills: GMP, Deviations, Investigation

Start of project: 01.10.2023

Duration of the project : 24 months

Project volume: 153600 Hour(s) 

Location: Neuchâtel area

Tasks:

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.
• Well-developed ability to constructively work across functional areas and levels to achieve results,
• Technical writing skills,

Qualifications:

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

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

c. 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.

d. Partner with quality assurance and impacted departments (production, quality control, warehouse, maintenance, etc) to ensure investigations are exhaustive.

e. Provide appropriate level of reporting and communication