18363-Quality Specialist- Dublin Contractor

This is a 9-month initial contract.

Purpose: 

The Quality Specialist will support QRM and compliance activities as required by the manager, in collaboration with the team. The Successful candidate will ensure that objectives are effectively achieved, and consistent with Company requirements to ensure compliance, safety, and reliable supply to our customers.

Responsibilities:

• Lead various QRM activities required on site

• Act as QRM facilitator and Risk lead, as applicable

• Schedule the completion of QRAs and track to completion including tracking to closure associated QRM CAPAs

• Present QRAs for concurrence at Site QRM Council

• Support for related Compliance deliverables in support of audits and inspection readiness

• Support for Change Management activities

• Provide compliance contribution to project teams and leads small projects

• Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming company and regulatory expectations and compliance changes/challenges

Requirements:

• Degree in natural or applied sciences (Biotechnology, Pharmacy, Biology, Engineering)

• Minimum 3-5 years of pharmaceutical and/or biotech industry experience in a Quality/Compliance / Validation related role

• Experience in startup biotechnology and drug substance facilities a distinct advantage

• Familiarity with Commissioning & Qualification lifecycle deliverables

• Sound awareness and understanding of the pharmaceutical business, especially with regard to quality, compliance, and regulatory requirements

• Experience in Quality Risk Assessments, as a participant, risk owner/author/facilitator

• Experience with change controls and deviations

• Experience in project management with demonstrated problem-solving capabilities

• Ability to operate efficiently in a complex matrix organization and global environment

• Ability to self-motivate and work independently and as a team

• Ability to lead and engage a cross-functional team

• Strong leadership and interpersonal influencing skills

• Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels