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.

Position Summary:

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.

What will you be doing?

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 may be required as defined by Supervisor and/or Manager.
Should be able to work independently and accountable for tasks and be able to drive tasks and escalating issues to supervision when needed.

Who will you be?

Excellent communication skills
Competent in Microsoft Word, PowerPoint, Excel
Good organizational skills
Flexibility
Results orientated
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
Minimum of Third level education and 2 years of relevant pharmaceutical experience or in lieu at least 5 years’ experience in pharmaceutical manufacturing role.

Our Benefits Include:

Highly competitive salary
Group pension scheme - Contribution rates up to 7%
Private Medical Insurance for the employee
Ongoing opportunities for career development in a rapidly expanding work environment
Succession planning and internal promotions
Education allowance
Wellness activities - Social activities eg. Golf, 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.

#LI-FD1

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

Learn more about Grifols

Technical Documentation Specialist

Benefits

Job Description