Senior Quality Assurance Specialist

Next Generation Recruitment; Dublin; On-site; EUR 60,000 - 80,000; Part time

Job summary

A well-known recruitment agency in Dublin is seeking an experienced Senior Quality Assurance Specialist/Manager for a 9-month contract. The successful candidate will support new product introduction and ensure compliance with GMP standards. Ideal candidates will have 5-7 years of experience in the pharmaceutical industry, focusing on batch release and documentation. This role requires strong collaboration with quality teams and provides the opportunity for ongoing process improvement.

Qualifications

• 5-7 years' experience in a pharmaceutical or biopharmaceutical environment.
• Strong batch release and GMP documentation experience.

Responsibilities

• Support the Qualified Person with batch certification activities.
• Prepare and review batch documentation packages in line with SOPs.
• Work closely with Supply Chain and Quality teams to ensure timely product disposition.
• Update SOPs, forms and training materials as needed.
• Contribute to NPI and tech transfer projects.
• Provide training and guidance to new team members.
• Support inspection readiness for corporate and regulatory audits.
• Participate in QMS activities including change control and self-inspections.
• Identify and implement opportunities for process improvement.
• Ensure all work is completed in accordance with GMP and regulatory expectations.

Skills

Strong batch release expertise

GMP environment experience

Familiarity with electronic quality systems

Education

Degree in science, engineering or a related field

Tools

DCA

Trackwise

Infinity

SAP

Job description

Senior Quality Assurance Specialist / Manager (9-month Contract)

Location: Dublin

Contract: Temporary, 9 months

A global biopharma organisation is seeking an experienced Senior Quality Assurance Specialist/Manager to support a busy period of new product introduction and technology transfer. This role requires strong batch release expertise and proven capability working within a GMP environment.

Key Responsibilities

Support the Qualified Person with batch certification activities.

Prepare and review batch documentation packages in line with SOPs.

Work closely with Supply Chain and Quality teams to ensure timely product disposition.

Update SOPs, forms and training materials as needed.

Contribute to NPI and tech transfer projects.

Provide training and guidance to new team members.

Support inspection readiness for corporate and regulatory audits.

Participate in QMS activities including change control, self-inspections, quality agreements, complaints and product quality reviews.

Identify and implement opportunities for process improvement.

Ensure all work is completed in accordance with GMP, regulatory expectations and internal quality standards.

Experience & Qualifications

Degree in science, engineering or a related field.

5-7 years' experience in a pharmaceutical or biopharmaceutical environment.

Strong batch release and GMP documentation experience.

Familiarity with electronic quality systems (e.g. DCA, Trackwise, Infinity, SAP).

The Next Step for you:

Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1 6498546