DPDS Quality Assurance Consultant

at  Capgemini

Industry
Engineering Services
Category
Quality Assurance & Test
Experience
Mid level
Experience
Mid level
Applications are considered on a rolling basis
Location: Multiple locations
Workspace type: Hybrid
Follow Capgemini Engineering
Contact Person
Chloé Olivet
chloe.olivet@capgemini.com
Job Description
For the drug development and supply department at our client, we are looking for a QA expert, interested in QA process improvement and optimization.
The Discovery, Product Development & Supply (DPDS) organization strives for a full understanding of the release requirements and post-release behavior of a Drug Substance (DS) and Drug Product (DP), providing expertise and support to the wider company whenever critical issues arise.
In this role, as a QA expert, you will be assigned to a team of international QA experts, and in charge of analyzing, improving, and optimizing the current processes in use.
More specifically, this involves analysis of inconsistencies or differences in QA processes in use at various sites, and proposing a new unified strategy that is in line with company policy, ISO, and FDA requirements, whilst still assuring flexibility and achievability of critical product supply.
Additionally, you will be called upon to help debottleneck current blocking issues (e.g. QC OOS, interruptions in product transfer between sites arising from QC/QA differences) with specific drug substances, and providing support in reaching agreement between production sites and global QA and supply.

QUALIFICATIONS:

Master’s degree in Pharmaceutical Sciences, or equivalent through experience
Profound knowledge and experience in use of pharmacopeia and compendia, especially at handling revisions and nonconformities
Working knowledge of operational facets of drug production, as well as QC and regulatory
Independent working skills and self-starter mindset. Willingness to go out and find issues and their root causes, without strict guidance
Strong planning and tracking skills, well organized and capable of handling multiple projects with respect to priorities and resources
Excellent organization, communication skills in a team setting
Understanding of regulatory guidelines for quality
Flexible and adapt quickly to constantly evolving business needs
Good written and verbal communication skills in English next to being fluent in Dutch or French
Practical experience in industry and knowledge of GMP regulations are an asset
“Can do” mentality and taking full ownership of your work
About the company
World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.
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 over 340,000 team members in more than 50 countries. With its strong 55-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 2021 global revenues of €18 billion

Interacts with the team to identify current issues, blocking points, inefficiencies, and delays
Proactively searches out stakeholders and experts, proposes solutions, and drives implementation of new and/or improved procedures
Leads and participates in meetings as appropriate to support team goals
Coordinates globally as the projects often span offices and time zones
Participates in trainings and continuous improvement initiatives
Ensures compliance with all relevant regulations, GMP and safety
Interprets the regulatory guidelines for quality and EHS and ensures their compliance