Purpose The Plant Quality Assurance (QA)
Senior Associate will report to a Senior QA Manager and is a core member of the site QA 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 labelling 24/5 shift pattern @ 25%, but this may change, and we will need people willing to be open to doing a 24/7 shift pattern if there is a business need to do so.
The shift patterns are as follows: 07:00 to 19:00, and 19:00 to 07:00 Responsibilities Perform all activities in compliance with 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 company policies.
Support continuous improvement and operational excellence initiatives Any other tasks/projects assigned as per managers request.
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.
Problem solver Advising and finding a complaint path forward Previous Production experience Team Responsibilities Purposeful Presence on the floor: Triage PPOF Defect Classification Pack Checks Audit Walks QA Lock outs
Quality Review:
Logbooks GMP Documentation Batch Records Deviations Protocols Qualifications Qualification : Science Degree /Engineering degree Skills: Quality Oversite Medical Device Assembly Quality Oversite Serialized Packaging & Labelling Shift Work Deviations Batch Record