For one of our clients in the pharmaceutical sector, we are looking for a freelance TOC Analytics for Cleaning Verification and Process Assurance Consultant.

1. Project Name
Qualification, Establishment, and Validation of TOC Analytics for Cleaning Verification and Process Assurance in Pharmaceutical Production and Launch Operations
2. Project Description
The service is requested within the framework of the project “Qualification, Establishment, and Validation of TOC Analytics for Cleaning Verification and Process Assurance in Pharmaceutical Production and Launch Operations.”
The objective of the project is to provide, by the end of the year, a fully qualified TOC analytical system, including an SOP framework and validated method, as a regulatory-compliant, robust, and reproducible analytical platform that meets regulatory requirements (e.g., EU GMP, USP <643>, Ph. Eur. 2.2.44).
The project involves the establishment and qualification of a TOC measurement system (Total Organic Carbon) to support the analytical assurance of cleaning verification during product launches and the commissioning of a new production process for our client.
The project includes the methodological establishment and validation of TOC analytics for the determination of organic residual contamination (including active ingredients, excipients, and cleaning agents) in rinse and swab samples.
The goal is to enable a secure, controlled, and audit-ready routine operation of TOC analytics following successful qualification and validation.
3. Detailed Scope of Services
The external contractor will receive from our client in advance all necessary system access, templates, contact lists, requirements, documents, and any other information required to perform the work.
The service includes the following tasks, which are to be carried out independently by the external contractor:

• Preparation and/or revision of GMP-compliant SOPs for the operation and maintenance of the TOC instrument, execution of TOC analytics, data handling, result evaluation, and deviation management
• Technical consultation regarding the implementation of SOPs into routine laboratory operations
• Independent execution of the qualification of the TOC measurement system (Shimadzu TOC-L) in accordance with GMP requirements
• Preparation, review, and maintenance of the associated qualification documentation
• Execution of method validation/verification according to internal requirements and regulatory guidelines, including but not limited to:
  • Accuracy
  • Precision
  • Linearity
  • Limit of quantification and limit of detection
  • Specificity (blank/interference assessment)
  • Robustness
  • Including project-specific sampling procedures
• Documentation of results in validation reports
• Establishment of the TOC method for operational cleaning verification processes

The objective upon completion of the service is the availability of a fully qualified TOC measurement system as well as the provision of a validated analytical method for routine operations for our client.
4. Requirements

• extensive knowledge in the establishment of TOC analytics, with ideally 3–5 years of professional experience in analytical chemistry, including project experience in the establishment and/or transfer of analytical methods.
• Experience in the pharmaceutical sector is required, particularly in the area of cleaning validation and analytical methods supporting cleaning validation.

The candidate should have experience with the following software applications:

• Shimadzu LabSolution TOC DB
• Microsoft Office
• Veeva Vault

The candidate should be familiar with and able to apply relevant regulatory standards and guidelines, including:

• GMP
• USP <643> / <645>
• Data integrity principles and guidelines (e.g., ALCOA+)
• strong expertise in analytical chemistry and regulatory requirements is essential.

International experience within a corporate structure is not mandatory for the initial local implementation phase but may be considered an advantage for future collaboration with global functions.
The candidate should be able to work effectively across relevant interfaces and departments and, where applicable, collaborate with other sites to ensure efficient knowledge sharing and exchange.

Start Date: 15/06/2026
Duration: Until 31/12/2026
Location: 30% Remote / 70% On-Site in Ingelheim am Rhein, Germany
Capacity: Full-time
Languages: Fluent German and English