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Document Control & System Management Specialist

  1. East Coast
  1. Contract
Competitive
26537
  1. CAPEX Projects
Date Posted08 Apr 2021
Document Control & System Management Specialist - Global Biopharmaceutical Client - USA

Our client is making a significant capital investment for a new biologics facility in the USA and requires a Document Control & System Management Specialist to work on the multi-billion-dollar project.


The Role:
  • The Document Control Specialist will be responsible for setting up and maintaining the technical documentation throughout the full lifecycle of a complex Biotech expansion programme.
  • Responsible for the 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.
Requirements:
  • Experience in a Document Control function on Large Scale Projects within the Biologics or Pharmaceutical industry. including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • 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.
  • Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
If this opportunity interests you, please apply today.



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