DESCRIPTION:

PE Global is currently recruiting for a Senior QA Associate on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.
This is a shift position.
The shift patterns are as follows: 07:00 to 19:00, and 19:00 to 07:00.

Skills required:

• Minimum Qualification: Science Degree /Engineering degree
• Strong attention to detail in terms of task execution and QA review.
• Proven in Risk Based Decision Making – ability to assess both the impact of an event that occurs and the suggested path-forward.
• Excellent written and verbal communication skills – ability to communicate across different teams/backgrounds & up/down different levels with the organisation.
• Strong organizational skills, including ability to follow assignments through to completion – ability to work well on own and as part of a dynamic team.
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
• Operational Excellence / Continuous improvement experience – ability to identify areas for improvement & implement said improvements.
• Previous Production experience
• Ability to do shift role 24/5 (at the moment shift schedule can change according to business needs, notice will of course be provided of ant change to cycle

ROLE RESPONSIBILITIES:

• Perform all activities in compliance with Amgen safety standards and standard operating procedures.
• Observe and provide real-time quality oversight and support for manufacturing on the floor.
• Perform purposeful presence on the floor audits.
• Perform manual pack check and deft assessment
• Perform Batch Review to support customer complaint investigations
• Provide quality support for triage and investigation of all classes of deviation events.
• Review/approve deviations for closure ensuring compliance with appropriate standards.
• Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.
• Provides training and advice to staff in order for them to perform their desired functions.
• Write, review and approve standard operating procedures in accordance with Amgen policies.
• Support continuous improvement and operational excellence initiatives
• Any other tasks/projects assigned as per manager’s request.

Skills required:

• Minimum Qualification: Science Degree /Engineering degree
• Strong attention to detail in terms of task execution and QA review.
• Proven in Risk Based Decision Making – ability to assess both the impact of an event that occurs and the suggested path-forward.
• Excellent written and verbal communication skills – ability to communicate across different teams/backgrounds & up/down different levels with the organisation.
• Strong organizational skills, including ability to follow assignments through to completion – ability to work well on own and as part of a dynamic team.
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
• Operational Excellence / Continuous improvement experience – ability to identify areas for improvement & implement said improvements.
• Previous Production experience
• Ability to do shift role 24/5 (at the moment shift schedule can change according to business needs, notice will of course be provided of ant change to cycle)

The QA Snr Associate will act as Quality point of contact for manufacturing operations and is responsible for oversight of:

• Medical Device assembly
• Serialized Packaging and labellin