Manufacturing Compliance Specialist
il y a 1 mois
Just-Evotec Biologics is seeking a motivated and provenManufacturing Compliance Specialist to join the J.POD Toulouse biotherapeutics Manufacturing Science and Technology team. Initially, you will focus on plant startup activities including Writing manufacturing SOPs, training, qualification and Facility flow definition. When production starts in 2025, you will transition to a key stakeholder ensuring for manufacturing and MSATthe training, Documentation, Deviations, Change Control and Improvements projects. The position reports to the MSAT Director.
The successful candidate has extensive experience in manufacturing compliance or operational quality of drug substance manufacturing derived from mammalian cell culture processes using single-use technologies in a clean room environment under cGMP controls, demonstrated success in building a culture of safety, quality and operational excellence, and native or fluent French proficiency and professional proficiency in English.
Responsibilities
Maintain Manufacturing compliance related metrics, communication and/or presentation of manufacturing compliance status.
Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across GMP Operations
Develop and implement training curricula, training materials and a proactive training program designed to ensure that manufacturing and MSAT employeecomply with cGMP requirements – and that they develop in-depth of knowledge and a high degree of operational proficiency.
Lead auto-inspection and manufacturing compliance strategy implementation efforts, including Manufacturing and MSAT inspection readiness, CAPA resolution, and timely response to audit activities.
Build and maintain a culture of safety, quality, and operational excellence among cGMP operations. Partner with manufacturing managers, EHS, Quality and Operational Excellenceleads and other cross-functional stakeholders to establish processes, routines and ways of working that reinforce constructive behaviours and mindsets.
Plan and implement activities for Operational Readiness (OR).
Author and submit revisions to controlled documents in support of GMP Operations, including SOPs, WIs and Master Batch records (MBRs) in accordance with the Quality Management System.
Lead on-the-floor troubleshooting and resolution efforts. Report and escalate issues per procedure. Support investigations.
Stay current with industry trends, regulatory requirements, and best practices in mammalian cell culture manufacturing processes, continuously seeking opportunities for innovation and improvement.
Requirements:
Education and experience:
Masters degree orEngineer with 5 years of experience, or Associates degree with 10 years of experience, in a scientific or engineering discipline in a cGMP manufacturing environment.
Strong experience with biotechnology processes.
Strong attention to detail, along with excellent verbal and written communication skills.
Strong decision-making skills, routinely demonstrated in highly complex environments.
Able to work with cross-functional areas such as quality, manufacturing, and engineering, in a matrix environment.
Ability to flex and quickly adapt to changing environment and competing priorities.
In-depth knowledge of and experience performing/using:
cGMP requirements as they apply to biopharmaceutical industrial production environments.
Quality Management System processes, to include risk assessments, change controls, deviations, CAPAs, etc.
Single-use technologies used for mammalian cell culture and purification biopharmaceutical production.
Demonstrated analytical skills with the ability to identify root causes of complex problems and develop effective solutions.
Strong leadership and interpersonal skills, with the ability to influence and collaborate effectively across the organization.
Excellent communication skills, both written and verbal. Able to organize, evaluate and communicate data and results. Able to present and defend records during internal and external audits.
Excellent organizational skills with the demonstrated ability to plan and prepare themselves and their team in a manner to ensure assigned activities are performed successfully and on-time.
Proven ability to manage a team performing multiple concurrent manufacturing activities.
Mandatory: Native or fluent in the French. Professional proficiency or better in English.
Join our team and play a critical role in driving operational excellence and ensuring the contributing to the success of Team J.POD Toulouse Apply now to be part of our dynamic and innovative organization dedicated to dramatically expanding global access to biopharmaceuticals.
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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