Our client based in Sligo are looking to hire a Quality Operations Compliance Specialist on an initial 12 month contract.

Shift Hours: Hours are 8-4.30 Monday to Friday

The Role:

Ensure that all products meet the standards required for marketed and investigational drug products.
Ensure that products and aseptic process simulations manufactured 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.

Responsibilities:

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 Incoming Raw Material checks, including product status maintenance (as required).
Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).
Administration of Quality Logs, e.g. QA Hold, Sample Request.
Lead operations floor daily walk around of manufacturing areas.
Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
Other support as deemed necessary

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.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

091 706717

Quality Operations Compliance Specialist