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Operations Documentation Specialist

Employer
Grifols
Location
Dublin West, Dublin
Salary
EUR35000 - EUR45000 per annum
Closing date
24 Feb 2023

View more

Sector
Manufacturing
Job Type
Permanent
Hours
Full-time

Job Details

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
  • Flexibility
  • 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

Company

Grifols is a global company that since 1909 has enhanced the health and well-being of people around the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative solutions and services in more than 100 countries.

Grifols Worldwide Operations Ltd. was established in 2013 in Dublin, Ireland. It serves as the management center for the global Bioscience Division overseeing treasury, risk management, supply and demand planning, regulatory, R&D and commercial functions.

It also serves as a hub for labeling, packing, final conditioning and distribution of finished plasma products to Grifols' worldwide network of commercial subsidiaries and distributors, with the exception of Spain and the United States. The site will also host an Albumin purification plant which is now under construction. www.grifols.com

Grifols Plant

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