QA Specialist

Location: Cork, Dublin
Posted On: 5/8/2017
Job Code: QA Specialist
Job Description
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
• Assists with the maintenance of programs, systems and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
• Assists with the review of manufacturing, environmental monitoring and quality control data for in-process and finished products.
• Assists with AQR preparation and completion regarding all aspects of producing quality products.
• Normally receives very little instruction on routine work, general instructions on new assignments.
• Provides guidance and technical knowledge to more junior staff.
• Develops strategies to implement changes to processes.
• Develops working engineering knowledge of products and Equipment
• Contributes to organization processes across functions and interacts effectively with the other team members.
• With guidance, prioritizes own work to ensure conformance to departmental and Project goals.
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
• Works directly with operating entities to ensure that deviation investigations, inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• May assist with compliance audits as required.
Category:Non-IT  code:new
Job Requirements
• Demonstrates working knowledge of current Good Manufacturing Practices (GMPs).
• Demonstrates knowledge of FDA / EMEA standards and quality systems.
• Demonstrates good verbal, written, and interpersonal communication skills.
• Demonstrates proficiency in MS Office applications.
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
• Requires sound knowledge of quality assurance systems, methods and procedures.
• Previous experience with Change Management, Validation and Commissioning Documentation requirements is strongly desirable.
• Demonstrates proficiency in Risk Management tools (e.g. HACCP and / or FMEA) is beneficial.

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Contact Details
Abhishek Joshi