Project Manager with experience in CSV and Qualification

Vor 5 Tagen

Frankfurt am Main, Hessen, Deutschland Global Market Solutions Germany Vollzeit 60.000 € - 90.000 € pro Jahr

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.

  • Qualification/Validation Specialist in GxP

    Vor 5 Tagen

    Frankfurt am Main, Hessen, Deutschland Global Market Solutions Germany Vollzeit 45.000 € - 70.000 € pro Jahr

    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...

  • Consultant Qualification

    Vor 6 Tagen

    Frankfurt am Main, Hessen, Deutschland Arcondis Group Vollzeit 60.000 € - 120.000 € pro Jahr

    Location(s): Frankfurt, BaselWork mode: On-siteCompany OverviewArcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for...

  • Project Manager

    Vor 5 Tagen

    Frankfurt am Main, Hessen, Deutschland Energy Job Search Vollzeit 50.000 € - 80.000 € pro Jahr

    Job DescriptionWe are looking to hire aProject Manager (m/f/d) to join ourGermany Teamin ourFrankfurt am Mainoffice and will be assigned to work on one or more projects. They will report to the Project Director, providing leadership and oversight for all aspects of day-to-day management of the project for which they are responsible.ResponsibilitiesSupport...

  • Project Manager – Outsourcing Governance and Oversight Vice President

    vor 1 Woche

    Frankfurt am Main, Hessen, Deutschland JPMorgan Chase Vollzeit 75.000 € - 150.000 € pro Jahr

    Join JPMSE OGO as a Project Manager and play a pivotal role in shaping our regulatory landscape. We're looking for a proactive professional who thrives in dynamic environments and is passionate about ensuring compliance and operational excellence. If you have a proven track record in regulatory change and Outsourcing regulations, this is your opportunity to...

  • Senior Project Manager

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland PM Group Vollzeit 80.000 € - 120.000 € pro Jahr

    Overview OverviewAre you an experienced Project Manager with experience of leading and executing projects throughout the full project life cycle from initiation to closeout?We have a fantastic opportunity for an ambitious Project Manager to join our growing team. With excellent people skills, you have a proven ability to work in partnership at all levels....

  • Senior Project Manager

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland Mane Contract Services Vollzeit 60.000 € - 120.000 € pro Jahr

    Key Responsibilities:Promote and enforce a strong safety and quality culture on site, implementing 'Right First Time' practices.Manage all aspects of site safety in coordination with the Project Manager and the Health & Safety Advisor, including setup and close-out of the project safety file.Ensure installation works comply with project specifications and...

  • Project Manager

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland -103a-4555-9084-a96da4a24055 Vollzeit 80.000 € - 120.000 € pro Jahr

    Company DescriptionFractera is committed to delivering exceptional building projects that set benchmarks in mission critical facilities. Combining PMC and Design Services, with heavy German experience, Fractera creates efficient and resilient spaces tailored to clients' needs. Our multidisciplinary team integrates advanced methodologies and technologies to...

  • SAP Senior Project Manager

    Vor 5 Tagen

    Frankfurt am Main, Hessen, Deutschland Infosys Vollzeit 80.000 € - 120.000 € pro Jahr

    Role – SAP Rollout ManagerTechnology – SAP S/4 HANAJob DescriptionToday, the corporate landscape is dynamic, and the world ahead is full of possibilities None of the amazing things we do at Infosys would be possible without an equally amazing culture, the environment where ideas can flourish and where you are empowered to move forward as far as your...

  • Project Manager

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland 275c726a-f773-449e-951f-0aa369aa2f98 Vollzeit 80.000 € - 120.000 € pro Jahr

    Project Manager (Out Buildings) - Germany, Frankfurt - 18 Month ContractLooking to take your career to the next level? We're recruiting for a high-impact pharmaceutical project located near Frankfurt. With major capital investment experience driving various facility build projects. This is a unique opportunity for a Project Manager to join a global leader in...

  • Project Manager

    Vor 6 Tagen

    Frankfurt am Main, Hessen, Deutschland 8f870ca1-fa50-453e-8286-d659a97eaf28 Vollzeit 80.000 € - 120.000 € pro Jahr

    Your career at Deutsche Börse GroupYour area of work:The Governance & Projects unit at Deutsche Börse AG serves as a central hub for governance-related topics. With a central function perspective, we manage large, cross-divisional projects that are not directly tied to business or IT.In this role, you'll gain deep insights into the business and operating...