Document Control and System Management
Our client is making a significant capital investment for a new biologics facility in the USA and requires a Document Control and System Management Specialist to work on the multi-billion-dollar project.
- Setting up and maintaining the technical documentation throughout the full lifecycle of a complex Biotech expansion programme.
- Execution of primary and complex protocols and procedures of the project document control system.
- Running of elementary tasks from the day-to-day document control workload.
- Coordinates and chairs Document Control meetings.
- Supports user requests for documentation and trains users in Document Management.
- Administers training system in Document Management, setting up users and exams as required.
- Investigates and responds to corrective actions related to Document Control and Training.
- Responsible for coordinating document change requests facilitates review, approval, and retention of Risk Management documents.
- Execute document control protocols and procedures in functional work areas Process incoming and outgoing documents including receipt, classification, registry, distribution, archiving, storage and retrieval.
- Develop knowledge and understand project management principles, quality systems, quality plan and working procedures. Implement elements of project management and quality within the scope of the project document control department.
- Front-line enforcement of approved document control procedures across the project organisation and interface with other project participants and team members.
- Continuously identify opportunities of enhancements in the document control process.
Experienced in document control function on large scale projects within Biologics or Pharmaceutical industry, including experience with design and construction projects for biopharmaceutical manufacturing facilities. The ideal candidate will be a goal focused, problem solver with strong leadership and communication skills.
- Experience in controlling qualification and validation documents.
- Work with all departments and with all levels of the organization, and with contract vendors engaged in design and construction.
- Ability to keep work pace and meet deadlines. Good organizing and planning skills.
- Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
- Proven success working well in a team environment with flexibility to react to changing business needs.
If this role interests you, apply today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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