CAPA & Compliant Investigator

CAPA & Compliant Investigator

at ClinChoice (View all jobs)
Ludwigshafen, Germany

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a CAPA and Compliant Investigator to join one of our partner companies, a large pharmaceutical company in Germany. This is an office-based role, in Ludwigshafen, Germany, 1 FTE, until the end of September 2025.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Main Job Tasks and Responsibilities:

1. Independent investigation to determine the cause (root cause analysis) within the quality systems (GMP and ISO).
2. Independent investigation of product complaints of pharmaceuticals and medical devices for the site.
3. Independent creation, review and approval of exception reports as well as independent planning, coordination and tracking of corrections, corrective and preventive measures using the Soltraqs database.
4. Support of the Quality Assurance Product Performance Manager in the CAPA area in the implementation of cross-site quality assurance measures in the area of investigation of exceptional events, as well as corrective and preventive measures.
5. Independent coordination of the system for deviations, as well as corrective and preventive measures (CAPA) at the site. Fulfilment of assigned special functions such as sample shipping.
6. Contact person for the specialist units on GxP-relevant issues that concern exceptional events/CAPA and complaints.
7. Maintenance of the Soltraqs database.
8. Support of quality control in the area of CAPA and process optimizations in the area of pharmaceutical production as well as in the area of medical device manufacturing.
9. Ensuring internal and external environmental protection and safety guidelines.
10. Ensuring the GMP or ISO status of the production areas.
11. Processing / collaboration in the creation of metrics (quality index).
12. Independently ensuring the implementation of new global and local requirements in CAPA and complaints.

Education and Experience:

1. Scientific degree or training and good knowledge of the pharmaceutical environment.
2. Practical experience around CAPA management and in the processing of deviations and complaints.
3. Knowledge of regulatory and legal requirements of pharmaceuticals and medical devices.
4. Knowledge of pharmaceutical analysis.
5. Experience in evaluating analytical results and methods.
6. Very good knowledge of German and English required.
7. Knowledge of Trackwise / SolTRAQs and SAP required.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Compliant Investigator, CAPA, Compliance, Regulatory, GMP, Pharmaceutical, German, English, CRO, Contract Research Organization, Outsourced, Outsourcing, Sponsor-dedicated.#J-18808-Ljbffr