QA Downstream Operations Associate Specialist

Asset Recruitment; Swords; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading biotech company in Swords seeks a QA Downstream Operations Associate Specialist. This role focuses on ensuring compliance with Good Manufacturing Practices and supporting production quality. Ideal candidates hold a bachelor's degree, have at least three years of experience in a GMP environment, and possess strong leadership and communication skills.

Qualifications

• 3 years of relevant post-degree experience in a GMP environment.
• Demonstrated flexibility and collaboration skills.
• Candidates must have either EU citizenship or a Stamp 4 in Ireland.

Responsibilities

• Ensure adherence to Good Manufacturing and Documentation Practices.
• Provide direct Quality support to production and review executed documentation.
• Support change management, deviations, and internal audits.

Skills

Leadership Skills

Communication Skills

Interpersonal Skills

Technical Writing

Problem Solving

Education

Bachelor's Degree in Scientific or Engineering Field

Tools

Lean Six-Sigma

Job description

ref. 01291

QA Downstream Operations Associate Specialist

Role Description
An amazing opportunity has arisen for a QA Downstream Operations Associate Specialist in a Biotech company in Swords.
Job Purpose:
In this role, you will be responsible for ensuring adherence to Good Manufacturing and Documentation Practices, Quality Manual and local procedures, spending significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements.

Functions include, but are not limited to, the following:
– Provide direct Quality support to production and support areas.
– Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.
– QA support, review and approval of C&Q, Performance qualification (PQ) & Process Validation documents.
– Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance & Calibration Programs.
– Provides support to internal audits and regulatory inspections.

REQUIREMENTS
– A Bachelor degree, in a scientific or engineering field.
– 3 years of relevant post-degree experience in a GMP environment: manufacturing, laboratory, quality, operations, technical, or regulatory function.
– Leadership skills coupled with good oral and written communication skills.
– Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment.
– Candidates must have either EU citizenship or a Stamp 4 in Ireland to be eligible for this role.

Technical competencies:
– Technical writing skills.
– Lean Six-sigma and problem solving tools.