Documentation Specialist

ref. 01233

Documentation Specialist

Exciting opportunity for a Documentation Specialist with our client, a leading multinational Pharmaceutical company based in Brinny, Co. Cork. This is an 11-Month contract opportunity with hybrid working options.

Responsibilities

• Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the EDMS from material supplied by the Vaccine IPT SMEs.

• Liaison with key stakeholders e.g., Quality, Change Control, SMEs etc. to guarantee 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 guarantee documents are prepared and updated in time for different stages of C&Q execution and production.

• Maintain the Site Master file for current effective cGMP documents on site at Brinny.

• 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 accordingly to guidelines and policies which impact own priorities and allocation of time to meet deadlines.

• Provides knowledge and experience in Quality Documentation Systems to the site.

• 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.

• 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

• 1-5 years' experience as a documentation specialist or equivalent in a pharmaceutical or a highly regulated environment.

• Advanced PC skills such as Excel, Word, PowerPoint.

• Experience in maintaining and updating excel schedules and trackers for small projects.

• Stakeholder management of multi decision makers, colleagues, peers, and cross functional teams.

• Qualification in a biological science subject is desirable.

• Knowledge and experience of GMP and GDP in a pharmaceutical environment.

• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g., Manufacturing, Quality, Engineering, Tech Services etc) is desirable.