Quality Specialist

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

Required Education

• Degree in natural or applied sciences (Biotechnology, Pharmacy, Biology, Engineering)
• Minimum 3-5 years pharmaceutical and/or biotech industry experience in 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 pharmaceutical business, especially with regards 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
• English fluency written and spoken (the Company language)

Interested candidates should submit an updated CV.

Please click the link below to apply, call William on 0214297900 or alternatively send an up to date CV to william.cunnage@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***