Documentation Control Specialist - Waterford
About the Opportunity
Reporting to the Luna project manager as a key member of the QC Luna team, you will play an integral role supporting the QC Luna Digital Paperless project ensuring the creation, storage, issuance, and retrieval of all documentation in a manner which meets cGMP requirements.
This encompasses but is not limited to QC Luna project tasks, QC Day to day activities.
About Sanofi Business Unit
The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is located in Waterford on Ireland's southeast coast.
Established in 2001 and now with more than 700 employees, the site has seen more than €600m invested in state-of-the-art infrastructure and technology. Diversification continues to bring new products to Waterford and the expanded site portfolio continues to create new opportunities.
- Define, manage, and maintain a documentation control system for QC projects & BAU cGMP documents.
- Manage, index, and control the QC on-site and off-site documents
- Create and maintain QC procedures.
- Train QC site personnel on the Documentation Management Processes and QC Luna project implementation.
- Define, manage, and maintain QC project key metrics ensuring site visibility, strong internal customer satisfaction and trending to support continuous improvement activities.
- Supporting and providing appropriate information to support Product Performance Reviews (PPR).
- Support and report right first-time documentation findings to support continuous improvement initiatives.
- Participate in internal audits, support all external audits and any key quality Initiatives.
- Ensure issuance and storage of QC and Projects documents.
To excel in this role, you will need to have:
- Leaving Certificate or equivalent and will preferably have secretarial and/or clerical qualification or accreditation
- Minimum of 3 years experience in similar role
Skills and Knowledge:
- Very good knowledge of cGMP in a regulated
- Excellent accuracy and attention to detail
- Strong Planning/Organising skill
- Customer Focus Driven with excellent interpersonal skills
- Good Presentation skills
- Working knowledge of computer systems
- Personal development and goal management skills
- Project Management skills and experience a distinct advantage
- Excellent communicator
- Flexible and adaptable- comfortable and open to change
- Works well across all levels of the organization
- Works on own initiative in a self-directed manner with minimal supervision
- Highly motivated and focuses on achieving results
- Excellent attention to detail
Play To Win Behaviours:
- Stretch: Ability to go out from comfort zone to serve better
- Take action: Prioritize outcomes over activities
- Act for Patients & Customers: Actively engage with them to understand their needs now and in the future
- Think One Sanofi: Believe that we'll go further together and have more fun doing it.