An amazing opportunity for a document specialist to join a multinational pharmaceutical company based in Cork. Please note this is a contractor position.
What you will do:
- Creating, editing, and formatting SOPs, Work Instructions, and other documents on the MSD EDMS (Veeva Vault) 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 the use of the Site Documentation System including Issuance, reconciliation, storage, archiving, and retrieval of cGMP documentation to support the manufacture & testing of our products.
- Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks.
- 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.
What skills you will need:
- 1-5 years experience as a documentation specialist or equivalent in a pharmaceutical or highly regulated environment.
- Experience in maintaining and updating Excel schedules and trackers for small projects.
- Advanced PC skills such as Excel, Word, and PowerPoint.
- 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.
For a confidential discussion and more information on the role, please contact Kevin Griffin
Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108