Documentation Specialist
Reference: | RK20963 |
Location: |
Cork
|
Qualification: | Degree | Experience: | 2-3 Years |
Job Type: | Fixed Term Contract | Salary: |
Not Disclosed |
Documentation Specialist
RK20963
Contract – 9 months
Cork
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
- Creating, editing, and formatting of SOPs, Work Instructions, and other documents 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
Experience and Education
- 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.
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.