QC Project Leader (m/w/d)
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Schweiz |
Freelance
Job title: QC Project Leader
Industry: PharmaSkills: Quality Control, Project Leader, Drug Product
Start of project: 19.02.2024
Duration of the project : 9 approx. 9 months
Location: Switzerland
Tasks:
- Acts as the technical and administrative QC project lead in complex, long-term DP projects.
- Serves as primary on-site QC interface for the customer and ensures the project is delivered in line with the agreed objectives.
- Anticipates innovations in the area of expertise and manages the implementation of new technologies in close collaboration with the customers
- Supports the QC (OOS/OOE etc.) Deviation and CAPA processes specific to their assigned customers; reviews and review investigation report
- Provides input to program management regarding QC capabilities and requirements for method qualification/validation.
- Reviews applicable regulatory guidance and internal policy documents to ensure compliance.
- Provides technical review of Statements of Work (SOWs) to support contract manufacturing activities.
- Provides QC representation to DP site and project team meetings. Responsible for relaying pertinent information such as production schedules and information requests to applicable QC groups.
- Writes, reviews, and/or approves Test Records/Forms, Sampling Plans, and Specifications.
- Leads tech transfer activities related to QC including generation of a QC master transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines
- Set-up of LIMS for Sampling plans related to customer projects
- Works in cooperation with QC Services to design qualification, and validation protocols.
- Performs QC assessment of new raw materials required to support GMP manufacturing and testing.
- Leads tech transfer activities related to QC including generation of a QC master transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines
- Set-up of LIMS for Sampling plans related to customer projects
- Works in cooperation with QC Services to design qualification, and validation protocols.
- Performs QC assessment of new raw materials required to support GMP manufacturing and testing.
Qualifications:
Key requirements:
- Doctoral or master degree in biotechnology or related field with significant experience in a biopharmaceutical environment.
- Practical experience and scientific expertise in DP relevant areas.
- Expertise in early and late phase process development.
- Able to analyse and solve complex problems that do not have routine solutions.
- Proven leadership skills to motivate and develop team members.
- Ability to communicate effectively at all levels across the organization.
- Fluency in English is required, German is a plus.
- Experience with method validation and technology transfer required
- Strong team orientation Structured, solution-oriented and well-organized working attitude
- In conjunction with program management team, helps develop loyalty and trust with customers.
- Knowledge of SAP and TrackWise systems a plus
Drug Product Background:
- Multiple years’ of experience in aseptic processing for Drug Product and associated installations e.g. filling line / isolator / depyrogenation tunnel / lyophilizer etc.
- Media Fill / Aseptic Process Simulation
- Environmental Monitoring (microbiological background/experience) and associated Cleanroom classifications
- Requirements for Visual Inspection/CCIT of Drug Product
- Moist Heat & Dry Heat Sterilization e.g. autoclave / SIP sterilization-in-place, depyrogenation experience and biological challenge with BIs/endotoxin.
Referenznummer: 14105
Branche: Pharma
Beginn des Projekts: 19.02.2024
Dauer: 9 Monate
Anstellungsart: Freelance
Kontakt
Lars Uhl