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Details

Quality Specialist


Reference:AMGS-537005 Location: Waterford
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Quality Specialist
Our client services Industries globally to deliver information technology & process control integration technology products to Pharmaceutical, Food & Beverage, Chemicals, Consumer Goods, Energy & Utilities, Telecoms, Oil & Gas and Metals & Mining Sectors. They are currently seeking a Quality Specialist based to join their team based in Waterford on a permanent basis.

Responsibilities
• Support the overall Quality Program (ISO 9001, 2015). This includes the generation, development, modification, and routing of Standard Operating Procedures, Work Instruction and Change Controls
• Work with internal team to obtain an in-depth understanding of the product and the documentation requirements
• Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience
• Updating procedural updates to SOPs
• Generation of Quality System documents
• Execute cGMP Standard Operating Procedures while adhering to all company quality standards and requirements
• Work with the Quality Manager to ensure that the requirements for each project are implemented according to the Customer’s requirements
• Involvement with the planning, preparation and execution of internal audits, following through on findings
• Work with other departments or functional areas to ensure complete compliance to the Quality Systems
• Perform other duties as directed by management

Requirements
• Minimum of 5 years of relevant pharmaceutical, medical device or software development experience
• Familiarity with CSV, SDLC and Software Development is desirable but not essential
• Ability to understand technical concepts and work with technical departments and personnel to achieve goals
• Ability to deliver high quality documentation while paying attention to detail
• Knowledge of electronic records requirements/compliance protocols (cGMP, GMP, FDA regulations, 21 CFR Part 11, 210, 211 and 820 compliance)
• Advanced understanding and practice of cGMPs
• Understanding of validation principals and techniques for software and computerized systems as applied in the pharmaceutical industry
• Ability to work in an organized and detail-oriented fashion
• Ability to manage multiple responsibilities with a high degree of self-motivation
• Ability to work both independently and in a team environment
• Excellent oral, written, and interpersonal communication skills
• Experience with IQ, IOQ, OQ, PQ and Validation Summary Reports
• Provide subject matter expertise during inspections and regulatory audits


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252