19134-Operations Documentation Specialist-Dublin Contractor

This role is on an 11 month contract with a view to extension.

Purpose

The Documentation Specialist will provide compliant, accurate, and timely documentation support. The Documentation Specialist is accountable to ensure the timely generation and approval of all key documents supporting the program schedule. Primary responsibilities include: coordinating and managing approval of key project documents, developing a site system for the tracking of documentation progress; generation of metric reports. Works with moderate work direction and is skilled and knowledgeable about the position.

Responsibilities

• Responsibility for the timely, accurate, and efficient management of documents including access and revision control.

• Manage and implement the floor documentation control system.

• Creation and revision of Standard Operation Procedures (SOPs), and Work Instructions (WIs) are required.

• Drive the Documentation life cycle system to ensure documents are approved in a timely manner as per scheduling requirements.

• Work with SMEs and various MSD internal and external stakeholders to ensure technical documentation updates are created and approved.

• Collaborate with QA, Supply chain, and Operations core functions.

• Ensure Compliance with all regulatory GMP, Safety, and Environmental Requirements.

• Report the status of documents, and identify areas of opportunities and action plans required.

• Coordination of Quality Notifications, CAPA, and overall Deviation management.

• Manage ‘’Live’’ Documentation updates and report progress on documents.

• Ensure effective planning, common understanding, and targets for specific documentation.

• Maintains a thorough knowledge of documentation needs.

• Provide updates on a regular basis to functional directors, and associate directors managers on deviation, documentation, and CAPAs.

• Identify Risks, Gaps, and Opportunities related to documentation – work with Area Owners and Subject Matter Experts to ensure documentation updates are approved.

• Collaborate with all the site functional areas and other MSD support teams.

Requirements

• A minimum of level 6 qualification in a Science, Engineering, or Project Management discipline.

Key Personal Skills

• Networking skills with peers and other work groups across the site.

• Enthusiastic contributor to the creation and development of our site culture.

• Exceptional communication skills and ability to communicate to multiple levels within the company.

• Experience with technical writing.

General

• Experience in the Pharmaceutical GMP regulated industry desirable.

• Excellent verbal and written communication skills.

• Ability to work independently and as part of a team in a cross-functional collaborative environment.

• Experience working with GMP Documentation Management Systems.

• High level of attention to detail.

• Demonstrated ability to manage multiple priorities against ambitious timelines. Strong planning ability.

• Strong problem-solving skills and ability to work cross-functionally.

Technical experience

• Should be proficient with Microsoft Office tools, (MS WORD/PowerPoint/ /Microsoft).

• Experience with SAP/Trackwise/Veeva Quality docs advantageous.