Job Description

Quality Operations Compliance Specialist

(Fully Onsite role)

 Primary Function:

• 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 at the 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 procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
• Other support as deemed necessary

Essential 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.

Cognitive Skills

• 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.
• Requires total commitment to quality and maintaining a high standard of work at all times.
• Demonstrates the highest levels of integrity and a strong work ethic at all times.
• Strong communication skills both verbal and written are required for the execution of this role.
• Strong interpersonal skills are required.
• Supports the principles of Perfect Performance
• May be required to support Cross functional teams and cost improvement projects.
• Expected to influence operations area owners to ensure that quality issues are identified, and appropriate corrective actions are implemented to maintain compliance.
• Provides guidance to the operations functions as required to maintain a compliant efficient relationship.
• Is a site SME on compliance and provides guidance
• 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.

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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