Quality & Regulatory Specialist

PE Global is currently recruiting for a Quality & Regulatory Specialist for a client site in East Cork –

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POSITION SUMMARY:

Under general direction of the Quality & Regulatory Manager, you will be primary responsible for quality systems and quality assurance activities, compliance with cGxP’s, in addition support release of finished product and investigations of product related issues and regulatory affairs.

This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate’s responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Ensures compliance with cGMP’s & Environmental, Health & Safety regulations.
• Ensure compliance & execute all activities to the Laboratories Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA
• Executes the finished product non-conformance process.
• Supports document reviews to ensure timely release of finished product.
• Executes all regulatory updates to product labelling to ensure timely & compliant launch of finished products.
• Manages & executes all routine regulatory updates & submissions of finished product labelling.
• Creation and maintenance of National Drug Codes (NDC) & Universal Product Codes (UPC)
• Creation and maintenance of Structured Product Labeling (SPL) for FDA submissions.
• Ensures the company and product is registered in the appropriate markets & with agencies as required.
• Reviews and approves product labeling, patient package insert and other product labeling.
• Executes the document control system & record retention.
• Develops, implements and maintains Standard Operating Procedures.
• Measure key performance indicators (KPIs) to monitor areas of responsibility and identify areas for improvement.
• Maintain familiarity with current regulatory trends.
• Establishes and promotes the maintenance of a safe, accident free and healthy work environment.
• Performs related duties as assigned.

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• Minimum requirement of a BSc in a scientific discipline; minimum of five (5) years in a cGMP facility in a Quality Assurance role.
• Essential to have good communication and attention to detail. Experience in the Pharmaceutical industry is essential.  Experience in Medical Device regulations is desirable but not essential.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

• Excellent oral and written communication skills
• Ability to effectively manage and participate in cross-functional problem-solving teams
• Ability to read and understand the English language for the purpose of following instructions
• Ability to develop and maintain cooperative working relationships with others.
• Ability to use good judgment in order to carry out detailed instructions
• Ability to work independently
• Excellent teamwork and interpersonal skills
• Ability to handle a variety of tasks simultaneously
• Excellent problem-solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
• Ability to apply critical thinking on review of all quality related procedures and documents
• Excellent attention to detail
• Artwork review/Regulatory experience desirable
• Supplier Quality
• Quality Systems
• Computer literate; Excel, Word, Document Management System, etc..
• Excellent knowledge of Quality Systems, Quality Assurance, cGxP and regulatory affairs.

WORK ENVIRONMENT:

• The work environment characteristics described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is generally quiet to moderate.

PHYSICAL AND MENTAL REQUIREMENTS:

• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:
• Sedentary physical activity requiring reaching, sifting, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing.
• Visual requirement is for close vision, distance vision, peripheral vision and ability to adjust focus.
• 90% or more time is spent looking directly at a computer.
• Associate is frequently required to stand, walk (or otherwise be mobile).
• Ability to deal with stressful situations as they arise.

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Interested candidates should send their CV to Audrey.mccarthy@peglobal.net or call 0214297900