Documentation Specialist

Orion Group Life Sciences are currently recruiting a Documentation Specialist on behalf of our Multinational Biopharmaceutical client based in Cork on an initial 11-month contract with huge potential to extend.

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

• 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 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.

Key Experience:

• 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.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.