Job Description

QA Manufacturing Compliance Specialist (Biologics)

Rotating Day and Evening Shift.

We are actively seeking to recruit a QA Compliance Specialist to become a key member of the Quality Team within a West of Ireland based Pharma manufacturer. This is an on site role with a rotating day and evening shift pattern.

Responsibilities

• Ensure that all products leaving the site meet the standards required for marketed and investigational drug products.

• Ensure that products and aseptic process simulations manufactured on site meet the requirements of the end users, regulatory authorities and of the company.

• Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.

• Provide quality oversight during the aseptic processing of products, including aseptic intervention observation.

• Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.

• Review/Audit of completed Batch Records.

• Review of Manufacturing Logs as required.

• Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)

• Completion of Line Clearance activities.

• Completion of Incoming Raw Material checks, including product status maintenance (as required).

• Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).

Requirements

• Third level degree in a science, quality or engineering discipline.

• Ideally previous experience in a quality role

• A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.

• Experience in aseptic processing gained within either a quality or operations role is highly desirable.

• A strong knowledge of regulatory requirements is required