Master Batch Documentation Coordinator Car-t

il y a 2 semaines

Gent, Belgique Johnson & Johnson Temps plein

Janssen Pharmaceutica is recruiting for the Master data batch documentation coordinator for the Manufacturing Excellence CAR-T EMEA organization, located in Ghent Belgium.
The Manufacturing Excellence CAR-T EMEA organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation, process system engineering, data architecture and continuous process verification and process investigation.
The team will drive process optimizations to enable seamless transition from clinical to commercial operations.

**Key Responsibilities**
- The Masterdata batch documentation coordinator has the responsibilities for supporting the document management process within a cell therapy

manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system in the automated business systems for document storage and retention, and document issuance and reconciliation.
- The individual will be the domain expert for process of document control for activities by mediafills in clinical phase up to commercial phase in the cell

theraphy processes E2E,
- The individual will serve as the Batch Document Control reviewer for new and revised batch protocols and documents to ensure compliance with global and site procedures
- Manage the periodic review process for master batch records and GxP documentation following document lifecycle requirements.
- The individual will be part in an effective implementation support team for ad
- hoc process investigations and will strategically prepare for optimizations in the batch documentation process domaine.
- Provides technical leadership in area of responsibility by effectively interfacing and collaborating with IT business system owners and key internal stakeholders and functions for these cell therapy processes E2E.
- Communicates effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best decisions in time-sensitive situations
- Provide technical leadership for Batch documentation Life-Cycle Management and drives continious improvement.
- Actively support and participate in all regulatory and internal audits of the processes.

**Qualifications**:
**Required**:

- GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 1).
- Operational experience with electronic quality systems.
- Experience with Document Management Systems (TruVault) is preferred.
- Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills.
- Flexible, highly motivated, with strong organization skills, ability to multi task with attention to detail.
- Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
- Proficient knowledge of Microsoft Office.
- Have advanced computer skills to increase department's productivity, as well as boarding technical and scientific knowledge.
- Fluent in written and spoken dutch and english

**Preferred**:
**Other**:

- Team player
- Ability to interact at different levels of the organization
- Ability to work under pressure, handle conflicting interests, and take decisions
- Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly

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