Johnson & Johnson
Engineering Documentation Lead
Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.
We are currently recruiting a Documentation Lead to join our contingent workforce on a growing team in Janssen Pharmaceuticals Cork for an initial 12 month contract.
About Janssen Pharmaceuticals
Janssen Sciences Ireland UC, (previously Janssen Biologics), is part of the Johnson & Johnson family of companies, the world’s most comprehensive and broadly-based manufacturer of healthcare products and related services. Our site in Ringaskiddy was established in 2005 on a 100-acre site with an investment of €500 million. We manufacture a range of biopharmaceutical products indicated for the treatment of conditions that include rheumatoid arthritis, psoriasis and cancer.
We are expanding our site to allow us to meet the critical needs of patients around the world. The expansion plans involve an investment of more than €300 million that will increase the existing manufacturing space by an additional 19,100m2, provide employment for up to 450 people during construction and an extra 200 people once completed.
- Management and development of a team of Document Controllers, ensuring efficient use of resources to meet company document management requirements
- Manage project data, document and work breakdown structure systems with aim to assist in continuous development and improvement of such systems.
- Manage documentation records for projects in compliance with all quality and regulatory requirements
- Be the primary point of contact for document management queries, and represent the system during regulatory audits/ inspections
- Manage the flow of documentation within the department
- Review and update technical documents (e.g. manuals and workflows)
- Represent the document management function in internal projects and provide expertise when required
- Development and deliverance of an effective document management training programme for staff across the business
- Works with all departments to ensure that records are archived in a regular manner and develops a schedule.
- Awareness & understanding of applicable company procedures
- Understands record requirements and ensures effective resolution of electronic record management system queries or requests.
- Use of Trackwise and electronic documentation systems to up-loading external documents to EDMS
- Responsible for the archival of GMP records in compliance with company record retention schedule.
- Supervises and guides subordinates to ensure that tasks are completed.
- Provide administrative support to Engineering and Projects departments
- A Batchelor’s Degree or equivalent.
- 5 + years’ experience and a proven track record of data management and document control for transactions or projects.
- Excellent written and oral communication skills.
- Ability to work under pressure and meet deadlines.
- Ability to work in a team, coordinate and enthuse colleagues and consultants.
- Strong initiative and the ability to proactively identify required tasks.
- Excellent attention to detail.
- Ability to maintain sight of the ‘big picture’ and overarching objectives at all times.
- Experience in working with document control systems complying with ISO 9.001 standard.
- Good IT skills, including experience with MS Word, Excel, PowerPoint, Access, SQL and SharePoint Designer.
- An organised approach to working, task prioritization and time management
If you meet our requirements and are interested in hearing more about our Documentation Lead, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!