QA Specialist – Manufacturing

Desired Skills: investigations,manufacturing,biologics

PE Global are currently recruiting for a QA Manufacturing Specialist – Investigations role to be based in our Bio client site in South Dublin on a 12 month initial contract:

Hybrid – when requested and approx. twice a month – must live on island of Ireland in order to be considered

Description:

The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following:

– Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing comprehensive compliant documentation of all findings.

– Clear and concise technical writing of complex investigations

– Drive improvements to the investigation process

– Present investigations to regulatory inspectors and internal auditors

– Clearly communicate investigation progress to impacted areas and leadership

– Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.

– Project management of the investigations end to end

– Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.

– Build effective relationships across functions.

– Navigate through ambiguity and provide a structured problem-solving approach.

– Able to apply inductive and deductive reasoning in the investigation process

Qualifications:

– Bachelor’s Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR * Associate’s Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) * 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment

– Detailed technical understanding of fill/finish operations

– Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.

– Experience leading complex investigations

– Experience participating in and leading cross-functional teams

– Experience in managing multiple, competing priorities in a fast-paced environment

– Experience presenting to inspectors during regulatory inspections and internal audits.

– Excellent technical writing

– Excellent presentation and communication skills, ability to communicate and collaborate with technical and management staff

– Ability to be flexible and manage change

To apply, please call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@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***