Dept: Quality Assurance

Reports to: Quality Operations Lead

Responsibilities:

• Comply with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release; Article 47 of Directive 2001/83/EC.
• Qualified Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the Product Specification File (PSF)/Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP) for products manufactured at Sligo site.
• To ensure that products manufactured at the site are manufactured in accordance with the relevant GMPs.
• The Quality Assurance Specialist / Qualified Person (QP) is responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.
• To disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch.

Requirements:

• Third level qualification in a science discipline with 5 years' experience in the pharmaceutical industry.
• MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
• 4+ years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
• 2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function.

Cognitive Skills

• High level of expertise is required to assess day to day quality issues.
• Must become familiar quickly with products and processes in order to assess quality issues.
• Must have good interpersonal skills.

Ownership/Accountability

Every employee has a personal responsibility to commit to the Companies Vision, to engage and align with the Strategic Imperatives, and to consistently execute in accordance with the Operational Pillars and the company Ways of Work.

Influence/Leadership

• May be required to support Cross functional teams and cost improvement projects.
• Provides guidance to suppliers as required to maintain a compliant efficient relationship.
• Provide technical leadership to functional areas and collaborates with key stakeholders.

Decision Making/Impact

• 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.
• Decision making within confines of agreed responsibility with Team Leader.

Supervision Received

• Individual is given authority to carry out their duties without close supervision.
• Reports to Quality Operations Lead.
• Goals are reviewed on a regular basis.

Supervision Provided

• No direct supervisory responsibilities.
• Close contact with personnel at all levels.

EHS Responsibilities

• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
• Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
• Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
• Attend all required EHS training and medical surveillance programs.
• Wear PPE as required.

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Geraldine Gormally on 0861071395  / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/  

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