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QC Project Lead (m/f/d) (Ref.Nr. LA3139)

We are looking for a person who can:

BRINE SA has been placing top specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.

Brine SA is looking for QC Project Lead for our Client in Wallis.

Key Responsibilities:

Within the matrix organization of the project team, you are in close contact with the analytical laboratories as well as with the program management, process development, production, and quality assurance departments, among others. Through excellent planning and management of the project, you will ensure timely and cost-effective processing of orders, even in the face of changing customer requirements and priorities.

  • Establish and maintain customer relationships
  • Preparation and supervision of production batches incl Sample logistics
  • Processing of change requests and deviations under GMP
  • Supervision of customer audits and inspections by authorities.
  • Calculating and monitoring QC costs in the project
  • Act as the technical and administrative QC project lead in complex, long-term DP projects.
  • Serve as primary on-site QC interface for the customer and ensures the project is delivered in line with the agreed objectives.
  • Anticipate innovations in the area of expertise and manage the implementation of new technologies in close collaboration with the customers
  • Support the QC (OOS/OOE etc) Deviation and CAPA processes specific to their assigned customers; review investigation report
  • Participate in the initial assessment of new products and processes.
  • Provide input to program management regarding QC capabilities and requirements for method qualification/validation. Review applicable regulatory guidance and internal policy documents to ensure compliance.
  • Provide technical review of Statements of Work (SOWs) to support contract manufacturing activities.
  • Provide 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.
  • Write, review, and/or approve Test Records/Forms, Sampling Plans, and Specifications.
  • Lead 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.
  • Perform QC assessment of new raw materials required to support GMP manufacturing and testing.
  • Coordination with testing sites.

You Should Have:

  • 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.
  • 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.
  • Proven leadership skills to motivate and develop team members.
  • Ability to communicate effectively at all levels across the organization.
  • 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, help develop loyalty and trust with customers. 
  • Knowledge of SAP and TrackWise systems a plus
  • Fluency in English is required, German is a plus.

To learn more about this opportunity please send your CV ASAP in Word format to Brine SA:

Workload: 100%

Salary: to be discussed

Language: Fluent Business English (oral and written),  German  of advantage

Ref: LA3139

Start Date: 15.03.2024
Duration: 31.10.2024
Location: Wallis
Salary: tbd

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    QC Project Lead (m/f/d) (Ref.Nr. LA3139)