Technical Documentation Specialist

2 weeks ago

Dublin, Dublin City, Ireland Grifols, S.A Full time
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

This position is to support Operations (Albumin Purification, Albumin Filling and Packaging) from the perspective of documentation, deviations, CAPAs and projects in order for smooth, efficient Operations. The Technical Document Specialist is responsible for using technical knowledge/concepts while partnering with manufacturing teams to create and revise manufacturing documents including PBRs, MBRs, SOPs, CCRs, Manufacturing Methods, deviation investigation reports, etc. Will ensure documents are streamlined, align with the manufacturing processes and procedures and comply with regulatory standards.

Primary Responsibilities for Role:

- Create, modify & streamline Operations documentation e.g. PBRs, MBRs, SOPs, OJT etc and ensure periodic review is completed within the required timelines.
- Consult with technicians to ensure ease of reading and understanding of documents, procedures, etc.
- Investigate, create, modify and execute Deviations, CAPA & Complaints, EC, Periodic review etc.
- Support Operations in Change Control and Risk Assessments administratively, by making sure that all documentation is in place and follow ups are appropriately completed to bring to closure.
- Collaborate with trainers to ensure clarity in regards to document revision training.
- Ensure correct revisions and documents are available when needed while also tracking all documents and their workflow.
- Provide reports and data defined by Supervisor and/or Management.
- Travel may be required from time to time to vendors or other Grifols sites internationally.
- Willing to upskill to as required by Grifols which may involve training course and/or further education.
- Perform other duties as may be required as defined by Supervisor and/or Manager.
- Should be able to work independently and be accountable for tasks and be able to drive tasks and escalate issues to supervision when needed.

Person Specification:

- Competent in Microsoft Word, PowerPoint, Excel
- Good organizational skills
- Flexibility
- Results oriented
- Knowledge and experience in SAP Production Modules an advantage
- Knowledge of manufacturing practices
- Knowledge of general GMPs of pharmaceuticals.
- Experience within upstream manufacturing, aseptic filling or Packaging operations
- Experience in technical report writing e.g. Deviations, audit responses in pharmaceutical industry
- Demonstrate strong technical and/or regulatory expertise and ability to adapt to changing circumstances
- Qualifications: Minimum of Third level education and 2 years of relevant pharmaceutical experience or at least 5 years' experience in a pharmaceutical manufacturing role.

Our Benefits Include:

- Highly competitive salary
- Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
- Private Medical Insurance for the employee
- Ongoing opportunities for career development in a rapidly expanding work environment
- Succession planning and internal promotions
- Wellness activities - Social activities e.g. Padel, Summer Events

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you.

Location: EMEA : Ireland : Dublin : Grange Castle (Dublin)

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