QA Specialist – Investigations

The Role:

PE Global are recruiting for a  Manufacturing Specialist – Investigations Lead to be based in Dun Laoghaire

12 Month initial contract – Hybrid

• Good technical writing – for all deviation incidents, the team must write a thorough write up. So, the candidate must be comfortable with writing clear information and ensure it is detailed.
• Good project management skills – for every deviation incident it will require the CW to manage timelines and expectations.
• Strong Communication – this goes hand in hand with the technical writing – as the CW will lead cross functional teams who may not have the technical knowledge. So the CW will need to ask the right questions and get the right information from people.
• Somebody with a Specialist QA background is suitable for the role. The team may not be in QA, but there’s a lot of compliance in place.

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

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey Mccarthy on +353 21 4297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net