20963 – Documentation Specialist – Cork Contractor

Purpose

Provide documentation (creating, formatting, tracking of SOPs, Work Instructions etc in the company (Electronic Document Management Systems) support to the Vaccines IPT team and the role will be reporting to the Vaccines IPT Associate Director.

Responsibilities

• Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the company EDMS from material supplied by the Vaccine IPT SMEs.
• Liaison with key stakeholders e.g., Quality, Change Control, SMEs etc. to ensure compliance, correctness, content, and delivery.
• Lead the tracking and maintaining of the project document delivery schedules for the team (using Excel).
• Engage with Change Control and the wider project team to ensure documents are prepared and updated in time for different stages of C&Q execution and production.
• Provides to the site knowledge and experience in Quality Documentation Systems.
• Responsible for use of the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of our products.
• Responsible for maintaining the Site Master file for current effective cGMP documents on site.
• Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks.
• Provides compliance contribution to project teams and leads small projects.
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
• Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
• Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
• Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Requirements

• 3-5 years’ experience as a documentation specialist or equivalent in a pharmaceutical or a highly regulated environment.
• Experience in maintaining and updating excel schedules and trackers for small projects.
• Advanced PC skills such as Excel, Word, PowerPoint.
• Stakeholder management of multi decision makers, colleagues, peers, and cross functional teams.
• Knowledge and experience of GMP and GDP in a pharmaceutical environment.
• Desirable: Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g., Manufacturing, Quality, Engineering, Tech Services etc).
• Desirable: Qualification in a biological science subject.
• Desirable: Evidence of Continuous Personal Development.