QA Manufacturing (Shop Floor) Specialist

Position Summary:

The QA Manufacturing (Shop Floor) Specialist is required for a new purification and aseptic filling plant for the blood protein albumin at Grifols Worldwide Operations (GWWO). Reporting directly to the QA Manufacturing Supervisor of Grifols Worldwide Operations (GWWO) the successful candidate will focus on the aseptic compliance aspects of Albumin Manufacturing both purification/formulation and aseptically filled product ensuring that operations are performed in accordance to the defined procedures maintaining GxP standards to provide assurance of product quality and patient safety. They will operate within a QA shop floor capacity and will be an on-the-ground key stakeholder of all core manufacturing departments including the wider QA network manufacturing maintenance automation and supporting functions.

What will you be doing:

General:

Ensure the quality of the work is maintained and inspection-ready in accordance with internal and external cGxP requirements and expectation.
Ensure adherence to GMP EU Annex 1 FDA and other applicable regulatory guidelines.
Support the cross-function readiness for batch certification ensuring all documentation related to the team is finalised within a timely manner.
Ensure personal compliance with all Training and Health & Safety requirements in accordance with company policy.
Support the teams overall performance with regular interaction with the wider site departments as defined via tier/triage-structures.
Support the teams general direction to ensure the team is successful in handling day-to-day operations in alignment with the functional directives.
Any other duties as required following consultation with the post holder

Quality Activities:

Performing daily GEMBAs and facility walk-through audits of the manufacturing facility inclusive of Grade A B C and D classified areas ensuring all functions are maintaining GMP compliance to defined procedures and working practices.
Performing routine observations of batch-related critical activities within the manufacturing processes (purification and aseptic filling) ensuring GMP compliance to defined procedures and batch records.
Support the manufacturing in-process control (IPC) and end-of-batch reconciliation processes ensuring batch-related manufacturing operations are compliant to the defined procedures and batch records.
Support in technical deviations investigations CAPA and change controls and provide Quality support to the manufacturing area.

Who you will be

Essential:

Working experience within a Sterile Pharmaceutical GMP-regulated facility.
Working experience in GMP cleanrooms inclusive of Grade A B C D classified areas and associated controls in-situ utilizing RABS technology.
Working experience with QMS processes both paper-based and electronic systems (e.g. Batch Records LIMS Veeva Vault Trackwise etc.)
Understanding of GMP regulation and guidance notably Annex 1 Sterile Manufacture and FDA Aseptic Guide.
MS Office

Desirable:

Understanding of Albumin manufacture Purification and Aseptic Filling in a bag presentation.
Verbal and written communication in Spanish and/or Catalan.

Educational Qualifications:

Minimum 3 years experience in a pharmaceutical manufacturing environment with EU GMP regulation. AND Bachelor or Masters degree in Pharmaceutical Sciences or Administration

OR

Minimum 5 years experience in aseptic manufacturing within a Quality or Manufacturing capacity preferably utilizing RABS technology (Grade A & B).

What we offer:

Highly competitive salary
Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
Private Medical Insurance for the employee (Irish Life)
Ongoing opportunities for career development in a rapidly expanding work environment
Succession planning and internal promotions
Education allowance
Wellness activities - Social activities eg. 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 were excited to hear from you

#LI-FD1

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

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