Spécialiste Assurance Qualité Produit – Pharmacien libérateur / QA Process specialist – Batch r[...]

Evotec WD; Toulouse; Sur place; EUR 40 000 - 55 000; Plein temps

Résumé du poste

Une entreprise de biotechnologie à Toulouse recherche un spécialiste QA Process pour garantir la conformité des enregistrements de lots et assurer la certification pharmaceutique. Le candidat idéal est un pharmacien reconnu en France avec au moins 2 ans d'expérience en production pharmaceutique, ayant de bonnes compétences organisationnelles et analytiques. Ce poste offre une opportunité de contribuer à l'amélioration de l'accès global aux produits biothérapeutiques.

Qualifications

• Pharmacien avec au moins 2 ans d’expérience dans un établissement de production pharmaceutique.
• Spécialisation en biotechnologies ou connaissance des environnements de production industrielle.

Responsabilités

• Assurer la conformité des enregistrements de lots.
• Participer à la certification pharmaceutique des lots.
• Rédiger et mettre à jour des procédures liées à votre domaine.

Connaissances

Compétences interpersonnelles

Esprit d’équipe

Compétences analytiques

Autonomie

Formation

Diplôme de Pharmacien reconnu en France

Outils

Word

Excel

Description du poste

As part of the start-up and operation of a biotechnology production plant, Just-Evotec Biologics EU is looking for a motivated QA Process specialist / Batch release PharmD who wants to be part of the Just Evotec adventure to improve global access to biotherapeutic products.

Reporting to the Quality Assurance Product Manager, you will be responsible for ensuring the reliability of information provided by people involved in the media and buffer preparation, USP (upstream process) and DSP (downstream process) steps. You guarantee the conformity of batch records and proceed with their pharmaceutical certification/confirmation. You are the main contact for biomanufacturing to ensure the processing of deviations and for development with a view to the introduction of new products. You ensure compliance with Good Manufacturing Practices and the company's Quality Policy.

You will therefore mainly be required to:

Participate in setting up and managing the department, including:

Participating in the design of bioproduct batch records

Reviewing completed media and buffer preparation and USP and DSP process batch records

Participate in the pharmaceutical certification of batches by delegation of the head pharmacist

Ensure the review and approval of documents relating to the conformity of starting materials

Ensure the follow-up and conclusion of non-conformity reports relating to the manufacture, control and storage of products.

Follow up on corrective and preventive actions and changes relating to your area of responsibility.

Ensure compliance with Good Manufacturing Practices and global procedures

You will also be responsible for:

Draft and update procedures and monitor regulatory changes within your scope.

Participate in the recruitment of potential future employees for your department, with the support of the HR department, and ensure their training, skills development and versatility, in line with company policy.

Collect and escalate data relating to product quality reviews and regulatory files for your pre-meter.

Report on your scope of activity to your line manager, including updating key performance indicators.

You will represent your scope during customer audits and authority inspections and play an active role in organizing and conducting these audits. You may also be asked to join the establishment's pool of internal auditors.

You are recognized for your interpersonal skills, your ability to listen and your team spirit. You enjoy a challenge and venture into unexplored areas.

You have excellent analytical, organizational and summarizing skills, and are highly adaptable and autonomous. You are fluent in both written and spoken English.

You are ideally pharmacist, with French recognized diploma and qualified to be registered at section B of the French pharmacist professional board, with at least 2 years' successful operational experience in a pharmaceutical production facility.

You have a specialization in biotechnologies and/or are familiar with biotechnological industrial production environments.

You have a good command of IT tools (Word, Excel).

Autres informations / Other information :

CDI / Permanent contract

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn .

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