Document Control Coordinator - Life Sciences & Quality Compliance
Capgemini
Capgemini
Capgemini Engineering seeks a Document Control Coordinator to join our Life Sciences & Quality Compliance team. We empower innovative companies through engineering and digital services. This role is crucial for strengthening quality compliance and driving operational excellence within leading Life Sciences organizations by managing robust document and quality systems.
Join a collaborative global community where you can shape your career and reimagine possibilities. Your contributions will directly impact our clients' ability to meet regulatory requirements and enhance their quality frameworks in a dynamic environment.
You will be responsible for the administration and lifecycle management of controlled quality documents. This includes executing new document creation, revisions, periodic reviews, publication, archival, and retirement.
Key duties involve reviewing documents for formatting, template adherence, metadata accuracy, version control, and completeness. You will also manage QMS workflows, coordinate with stakeholders, maintain essential document control records, and track open requests to ensure SLA commitments are met, escalating risks as needed.
Support will be provided for document retrieval, traceability, regulatory inspections, and audit preparation. Generating performance reports, backlog metrics, and compliance dashboards will also be part of your role, ensuring data integrity and accuracy.
A Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Medical Sciences, Engineering, Quality Management, or a related field is required. Candidates must possess at least 4 years of experience in Document Control, Document Management, Quality Operations, Regulatory Support, Compliance, or similar functions.
Mandatory experience within regulated industries such as Life Sciences, Pharmaceutical, Biotechnology, Medical Device, or Healthcare is essential. Proven hands-on experience in Compliance, Regulatory Affairs, Quality Assurance (QA), Quality Systems (QMS), or regulated operational environments is crucial.
Strong knowledge of controlled document lifecycle management, records management, audit readiness, and data integrity principles is expected. Familiarity with Electronic Document Management Systems (eDMS) or controlled repositories like Veeva Vault, MasterControl, OpenText/Documentum, or TrackWise is a significant advantage.
Capgemini
Pharmaceuticals