Operations Documentation Specialist
This position is to support the Packaging Operations in GWWO from the perspective of Documentation, IT applications, Projects and Training in order for the smooth, Lean and efficient Packaging operations
What your responsibilities will be
- Review production batch records (PBR/MBR) to ensure GMP compliance, accuracy of data and execute required SAP transactions.
- Monitor and review day to day batch status' on SAP and upload batches to SAP ATTP.
- Create, modify & streamline Packaging operations documentation e.g. PBR's, SOPs, OJT etc and ensure periodic review is completed within the required time lines.
- Provide SME support to the team on consumption of batches and ensure closure of batch in SAP in line with KPI's
- Investigate, create, modify and execute Deviations, CAPA & Complaints, EC, Periodic review etc.
- Involvement in New projects in Packaging operations as required
- 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
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
- Excellent communication skills
- Competent in Microsoft Word, PowerPoint, Excel
- Good organizational skills
- Results orientated
- Knowledge and experience in SAP Production Modules an advantage
- Minimum of Third level education and or in lieu at least 2 years' experience in pharmaceutical manufacturing role.
- Previous Technical writing experience in pharmaceutical industry
- Experience in report writing e.g. Deviations, audit responses