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Apply for this job
Details
Documentation Specialist
Reference: | RK20963 | Location: |
Cork |
Qualification: | Degree | Experience: | 2-3 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Documentation Specialist
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 [email protected] for further information.
Limerick Clinical Research Diagnostics Scientific Dublin Cork Biotechnology Manufacturing Executive Validation Engineer PhD Scientist IT Chemistry Quality Assurance Laboratory Scientist Product Development Engineer Medical Device Allied Healthcare Cork City Academic Supply Chain Microbiology Packaging Engineer Sales and Marketing Engineering Pharmaceutical Academic Medical Affairs Project Manager Biopharmaceutical Mayo Connected Health Sales and Marketing Quality Control Supply Chain Life Science Quality Engineering Pharma Sales
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS