PE Global is currently recruiting for QA Compliance Specialist for a Client site in Sligo:
This will be a 12-month initial contract role – days role 8-4.30 Monday to Friday – onsite.
Primary Function:
* Ensure that all products leaving site meet the standards required for marketed and investigational drug products.
* Ensure that products and aseptic process simulations manufactured at 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.
Key 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 procedures, 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.
* 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.
* Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
* Requires proven problem-solving skills and the ability to adapt to new requirements.
* Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
* Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
* Decision making within confines of quality systems in relation to applicable regulatory and international standards.
* Expected to handle all day to day quality issues/queries from the operations function; however, if a major problem occurs, they will confer with relevant personnel or Team Leader.
Interested candidates should submit an updated CV, marked for the attention of Audrey.
audrey.mccarthy@peglobal.net or 00353 21 4297900
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