NIRAS Ireland is currently recruiting a Quality Operations Compliance Specialist to join our client's team based in Sligo. This is a 12 month contract role based 100% onsite.
The role:
The Quality Operations Compliance Specialist will ensure that all products leaving the production site, as well as aseptic process simulations, meet the standards required for marketed and investigational products, and satisfy the expectations of end users, regulatory authorities, and the company. This role provides quality and compliance oversight and support to the Operations function to ensure products are manufactured in accordance 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.
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.
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