QA Downstream Operations Associate Specialist

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.