Project Manager with experience in CSV and Qualification

GMS is an operational consultancy with expertise in data and digital systems. Whether digitalisation, data & analytics or compliance - our consultants are the missing piece of our customer’s digital puzzle. We empower their ongoing digital transformation and transform challenges into opportunities. We're part of the MoOngy Group, a more than 18 years old European network of companies with a focus on IT & Engineering expertise.

We are looking for a Project Manager with experience in CSV and Qualification

We are seeking a highly skilled Project Manager to oversee the implementation of new equipment.

The ideal candidate will possess expertise in Computer System Validation (CSV) and equipment qualification, with the ability to set up comprehensive documentation for the qualification process.

Fluency in German and residency in Germany are mandatory.

Key Responsibilities:

• Project Management: Monitor project progress, identify potential issues, and implement corrective actions as needed.

• Computer System Validation (CSV): Oversee the CSV process, ensuring compliance with regulatory requirements and industry standards; Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Equipment Qualification: Conduct risk assessments and implement mitigation strategies to ensure equipment reliability and safety; Collaborate with vendors and suppliers to ensure timely and accurate delivery of equipment and services
• Communication and Reporting: Prepare and present project reports and documentation to regulatory authorities as required.

Qualifications:

• Proven experience (3-5 years) as a Project Manager in GxP, specifically in equipment implementation and qualification.
• Strong knowledge of Computer System Validation (CSV) and equipment qualification processes.
• GxP Knowledge is a must
• Excellent documentation skills, with the ability to create comprehensive qualification documentation.
• Strong organizational and time-management skills, with the ability to manage multiple priorities.
• Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
• Fluency in German (mandatory) and proficiency in English.
• Residency in Germany, with the ability to work in a hybrid model from Essen

What you get from us

• We are a growing company with ambitious targets that stands for expert knowledge, integrity and open-mindedness.
• As a consultant, you will implement a wide range of projects for our well-known customers and offer them your growing expertise
• Your development is supported by a coach, further training, our in-house learning platform and an internal IT & data network
• Work-life balance is important to us - you enjoy home office options, have the choice between regional or Germany-wide projects and our philosophy is a 40-hour week
• We also offer security and stability - our employees are employed on a permanent basis

At GMS we defend equality and diversity. We create a safe and diverse environment where all the opportunities are equal for all the employees. We do not discriminate based on age, ethnicity, sexual orientation, gender, disability or any factor other than merit.

All applications with skills for the position are welcome!

Would you like to apply with us? Then we look forward to receiving your CV.