Quality Control Specialist

**Capgemini Engineering combines, under one brand, a unique set of strengths from across the Capgemini Group: world-leading engineering and R&D and digital manufacturing expertise. With broad industry knowledge and cutting-edge technologies in digital and software, Capgemini Engineering supports the convergence of the physical and digital worlds. Combined with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 52,000 engineer and scientist team members in over 30 countries across sectors including aeronautics, automotive, railways, communications, energy, life sciences, semiconductors, software & internet, space & defense, and consumer products.**

**Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology.**
**The Group is**
**guided every day by its purpose of unleashing human energy through technology for an inclusive and**
**sustainable future**
**. It is a responsible and diverse organization of 270,000 team members in nearly 50 countries. With its strong 50-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast-evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering, and platforms. The Group reported in 2020 global revenues of €16 billion.**

**Our Offer**:
**At Capgemini, we see things differently.**

**Vision - The business value of technology comes from and through people.**

**Your career matters to you and is important to us too. Because your goals and needs are constantly**

**evolving, we offer visibility, leeway, and support to help you grow and progress in your career.**

**We promote a culture of diversity. We believe working with talented individuals from different backgrounds and points of view is a strategic advantage and an ongoing opportunity. Diversity enriches our creative solutions and adds value for our clients.**

**Our Shared values have been at the heart of the group since our formation. They are honesty, boldness, trust, freedom, team spirit, modesty and fun. These values influence the way we meet client needs while respecting the regulatory requirements of each country in which we operate, and the way we promote ethically sound practices within Capgemini and in our partnerships.**

**Capgemini is committed to building a workforce of employees with diverse backgrounds and work experiences.**

**Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace.**

**Main Responsibilities**:
**A position is available to join one of the global Laboratory Execution Systems Team. Based at our client site you will support a large on-site Quality Control function by maintaining and supporting our Laboratory Quality Control computerized systems.**

**Utilizing your experience in either Engineering, IT, R&D or Quality in this hybrid position you will ensure compliance and perform quality management activities related to GxP qualification/validation and change management by observing GxP regulatory requirements and industry best practices surrounding the GAMP5 Framework, FDA 21CFR Part 11 and EU Annex 11.
- **Experience in setting up QC lab systems at sites with GMP/GXP experience in system qualification.**:

- **Analyse requirements gathered by the QC Project team so the Provider can configure the software as required.**:

- **Create the following documents: Standard Operating Procedures (SOPs), Work Instructions (WI), system administration manuals and validation documents with the requirements based on documentation provided by Third Party Manufacturer.**:

- **Create users in the QC LES (Lab Execution) system and set up administration during the deployment phase of the software.**:

- **Gather and analyze IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) requirements to support the Validation team.**:

- **Build a dataset and data model to meet the requirements of users in sites.**:

- **Install and settle the support systems for laboratories, including atomic absorption systems, Gas Chromatography-Mass Spectrometry (GC-MS), time-of-flight mass spectrometry (Maldi TOF), Microsequencer, and Titrator.**:

- **Other activities related to the Lab Execution System (LES) supporting the new site and related projects**

**Your skills and experience**
- **Experience working in a GxP environment (Industry, Laboratory, University, Laboratory Equipment Vendor or similar)**:

- **Experience with CSV regulations like FDA 21CFR Part 11 and EU Annex 11**:

- **Experience with GAMP5 Framework**:

- **Understanding of laboratory equipment, systems, and software**:

- **Connect engineering, quality, and IT streams and requirements**:

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