Cleaning Validation

Il y a 3 semaines

Strasbourg, Grand Est, France Meet Life Sciences Temps plein

Gratuit avec email ou Google

Enregistrez cette offre et organisez votre recherche

Créez un compte gratuit pour enregistrer des offres d'emploi, créer des alertes et revenir à cette liste depuis votre tableau de bord.

Enregistrer le travail Enregistrer et créer une alerte

Gratuit avec email ou Google

Strasbourg, France | Contract | 5 Days On-Site

Please note: This position requires a full-time on-site presence in Strasbourg, five days per week. Previous professional experience working within a pharmaceutical manufacturing environment is essential. If you cannot commit to five days per week on-site or do not have previous pharmaceutical industry experience, please do not apply.

We are currently recruiting for an experienced Cleaning Validation & CSV Specialist to support a major pharmaceutical manufacturing expansion project in Strasbourg, France.

The project involves the installation, commissioning and qualification of new pharmaceutical manufacturing equipment and production areas ahead of operational and GMP readiness.

Working from the user/operations side, you will be responsible for preparing and maintaining documentation associated with new equipment from a Cleaning perspective, while ensuring relevant Computerized System Validation (CSV) requirements are appropriately addressed.

Key Responsibilities

Prepare and maintain user-side documentation associated with new pharmaceutical manufacturing equipment.
Support documentation activities from the Cleaning and Cleaning Validation perspective.
Ensure relevant equipment and systems meet applicable CSV requirements.
Support documentation in accordance with GMP and GAMP 5 principles.
Develop and maintain the Operational Handbook for new equipment and processes.
Prepare, review and update relevant SOPs, procedures and operational documentation.
Work closely with Cleaning, Validation, Engineering, Quality and Manufacturing stakeholders.
Support documentation readiness as new equipment progresses through commissioning, qualification and operational handover.
Ensure documentation is complete, compliant and ready for use within the GMP manufacturing environment.

Experience Required

Previous experience within a pharmaceutical manufacturing environment is essential.
Strong experience with Cleaning Validation and/or cleaning documentation.
Practical knowledge of Computerized System Validation (CSV) within a GxP environment.
Understanding of GAMP 5 principles.
Experience preparing and reviewing GMP documentation, SOPs and operational procedures.
Experience supporting the introduction or validation of new manufacturing equipment.
Strong documentation and stakeholder-management skills.
French language capability is required due to the site-based nature of the project.
Must be available to work on-site in Strasbourg five days per week.

This is an opportunity to support a significant pharmaceutical expansion programme and take ownership of critical Cleaning, CSV and operational documentation as new manufacturing equipment moves towards GMP operation.

#J-18808-Ljbffr

Cleaning Validation

Enregistrez cette offre et organisez votre recherche

Key Responsibilities

Experience Required

Emplois similaires à Strasbourg

Offres similaires

Amériques

Europe

Asie / Océanie

Afrique

Cleaning Validation

Enregistrez cette offre et organisez votre recherche

Key Responsibilities

Experience Required

Emplois similaires à Strasbourg

Offres similaires