Are you an imaginative writer who can dream up the perfect word or craft a compelling narrative? Our client, a pharmaceutical multinational is currently looking for a Technical Writer/Compliance Specialist to join their team in Limerick. This is initially a 9-month contract with a strong possibility of extension. This is also a hybrid working role.
You’ll be responsible for providing support for the technical/validation documentation and support activities within NPI Team to ensure that all activities associated with change control and general documentation support tasks are completed in a fully compliant manner in accordance with the requirements of our client Validation/Quality Policies and Procedures. The role requires collaboration with Quality Engineering to ensure our client’s Validation/Quality Policies and Procedures are maintained.
Role and Responsibilities:
- Perform technical writing activities and assist the project engineers in the generation of validation documentation including URS’s, FAT’s, SAT’s, test plans, deviations, and discrepancies.
- Update and edit Operations Procedures, Work Instructions, project manuals, project presentations, and reports.
- To aid with Change Control process to ensure that change implementation activities and deliverables are coordinated effectively to meet both the TRB and CCB requirements and timelines.
- Help coordinate FMEA sessions with Validation and Engineering as needed.
- Assist with attachment and upload of deliverables associated with change control.
- Help with non-critical Validation execution under the direction of the Validation Engineer.
- Assist with purchasing and spare parts ordering
- Ensure accuracy and consistency of the technical/validation documentation.
- Ensure all quality/validation documents are authorized and appropriate compliance approval is gained.
- Update procedures as required.
- Qualification in an appropriate discipline (e.g., Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base you will have a minimum of 3 years of experience working in a quality role in a pharmaceutical or health care manufacturing environment.
- GxP or GMP or CRF P21 is an essential regulation required for working in Medical devices or Pharma.
- Excellent written, presentation, communication, and investigation skills.
- Ability to work on own initiative, without direct supervision from management.
- Team player with an ability to work well across various departments on site as well as business partners.
- Direct experience and in-depth knowledge of automation platforms are desirable.
- Deadline-focused individual.
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Contact: Tara O' Sullivan
Telephone: 061 209 510
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