Qualified Person, Quality — Batch Release Expert (Hybrid)

West Pharmaceutical Services, Inc; Dublin; Hybrid; EUR 82,000 - 104,000; Full time

Benefits offered by this job

Performance-based bonuses

Total rewards programs

Job summary

West Pharmaceutical Services, Inc. in Dublin seeks a Qualified Person (QP) to make disposition decisions for human medicinal products and IMPs assembled at West, releasing them for MAH transfer. The role requires batch certification and EU compliance knowledge, with reporting to the Director of Quality.

Travel up to 20%; hybrid onsite three days per week; join a global company offering development and regulatory training, and opportunities across North America, Europe, and Asia-Pacific.

Qualifications

• EU Directive 2001/83/EC Article 49 as amended and EU GMP including IMP requirements.
• Hold a 4-year degree programme in pharmacy, chemistry, biology, microbiology or equivalent.
• Hold a HPRA-recognized postgraduate qualification to act as Qualified Person, such as the Graduate Diploma in Pharmaceutical Manufacturing Technology at Trinity College, RCSI or UCC.

Responsibilities

• Make disposition decisions for human medicinal products and IMPs assembled at West and released to MAH.
• Certify batches in line with EU Directives and EU GMP.
• Provide regulatory compliance guidance to the West Quality Team and report to the Director, Quality.
• Ensure QMS compliance and participate in regulatory inspections and responses.
• Communicate with MAH, HPRA and regulators as needed.
• Stay informed on regulatory updates and trends impacting West operations.

Education

EU Directive 2001/83/EC Article 49 amended

4-year degree programme in pharmacy, chemistry, biology, microbiology or equivalent

HPRA-recognized postgraduate qualification to act as Qualified Person (Graduate Diploma in Pharmaceutical Manufacturing Technology at Trinity College, RCSI or UCC)

Job description

West Pharmaceutical Services, Inc. in Dublin seeks a Qualified Person (QP) to make disposition decisions for human medicinal products and IMPs assembled at West, releasing them for MAH transfer. The role requires batch certification and EU compliance knowledge, with reporting to the Director of Quality.

Travel up to 20%; hybrid onsite three days per week; join a global company offering development and regulatory training, and opportunities across North America, Europe, and Asia-Pacific.