QA Manufacturing Specialist

Grifols Worldwide Operations Limited; Dublin; On-site; EUR 80,000 - 100,000; Full time

Job summary

A pharmaceutical manufacturing company located in Dublin seeks a QA Manufacturing Specialist to ensure aseptic compliance and uphold GMP standards in their new facility. The ideal candidate will have experience in a GMP-regulated setup, proficient in QMS processes, and possess a relevant degree. The role offers competitive salary, career development opportunities, and wellness activities. Interested candidates are encouraged to apply regardless of doubts about qualifications.

Benefits

Highly competitive salary

Group pension scheme

Private Medical Insurance

Career development opportunities

Education allowance

Wellness activities

Qualifications

• Minimum 3 years' experience in a pharmaceutical manufacturing environment with EU GMP regulation.
• Minimum 5 years' experience in aseptic manufacturing preferred.

Responsibilities

• Ensure compliance with cGxP requirements.
• Perform facility walkthrough audits and maintain GMP compliance.
• Support manufacturing and quality activities.

Skills

Experience in a Sterile Pharmaceutical GMP-regulated facility

Experience in GMP cleanrooms using RABS technology

Familiarity with QMS processes

Understanding of GMP regulation and guidance

Proficient in MS Office

Education

Bachelor's or Master's degree in Pharmaceutical Sciences or Administration

Tools

Batch Records

LIMS

Veeva Vault

Trackwise

Job description

Position Summary

The QA Manufacturing 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 team’s overall performance with regular interaction with the wider site departments, as defined via tier/triage-structures.

Support the team’s 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 Master’s 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 – we're excited to hear from you.

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Learn more about Grifols

Req ID: 534257

Type: Regular Full-Time

Job Category: Quality