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