description du poste

About Us: Our Client is a leader in the pharmaceutial industry, committed to innovation and excellence. We are seeking a highly skilled MSAT Environmental Monitoring (EM) Subject Matter Expert to join our dynamic team.Objectives of the mission: Roll out environmental qualification projects Review environmental risk assessments Other actions associated with environmental monitoring and contamination Profile: MSAT EM Expert is a Subject Matter Expert position. Their expertise includes but is not limited to environment qualification, manufacturing environment, analytical testing and product know-How. MSAT EM expert leads environmental monitoring (EM) performance qualification (PQ). • Lead EM PQ. Ensure a proper communication between stakeholders. Ensure that all qualification steps are followed per the effective EM PQ SOP. • This includes also when necessary execution of validation tasks. Ensure validation documentation is clear, scientifically based and in compliance with European GMP, ISO13485 expectations, 21CFR820. • Provide exhaustive planning and accurate budget evaluation for projects. • Lead technical investigations and support experiments for demonstration of potential root causes.Key Responsibilities:Lead Environmental Monitoring (EM) Performance Qualification (PQ) activities.Develop and implement EM strategies and protocols.Ensure compliance with regulatory standards and guidelines.Analyze and interpret EM data to drive continuous improvement.Collaborate with cross-functional teams to support manufacturing operations.Provide training and guidance on EM best practices.Qualifications:Proven experience in Environmental Monitoring (EM) and Performance Qualification (PQ).Strong knowledge of regulatory requirements and industry standards.Excellent analytical and problem-solving skills.Fluent in French and English.Strong communication and interpersonal skills.Ability to work independently and as part of a team.About Planet Pharma:ABOUT PLANET PHARMAPlanet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.