Quality Operations Associate

Desired Skills: quality operations

QA Resources are currently recruiting for a Quality Operations associate on contract to November-

East Cork based , fully on site, shift role

Description:

We are currently seeking a Quality Operations Specialist who reports to the Compliance Leader with a dotted Line to the People Team Lead.

MAIN DUTIES AND RESPONSIBILITIES:

Area SME

• To provide process and technical support on the shift and as required; cross functional projects.
• Act as a key point of contact between support departments and shift personnel
• Pro-actively surface and support the resolution of day to day process/technical issues as appropriate in a timely fashion.
• Support Shift personnel in achieving greater Batch Record Right First Time and reduced Batch Review cycle time.
• Handover: ensure detailed shift Compliance handovers are prepared and completed

Timely initiation & close out of compliance

• To carry out effective ‘root cause’, high quality investigations and technical writing to support the shift and batch related processes; engaging operators and support departments.
• Support Close out of Internal Audit actions/CAPAs
• Support cross-functional investigations as required.

Actively participate in CI & Projects

• To support & engage with Shift personnel in implementing Lean, GMP, & EHS Continuous Improvement programs
• Support cross-functional projects as required
• Process and implement suggestions as appropriate
• Contribute to yield and efficiency improvement on Shift

Inspection readiness/ housekeeping/6S

• Liaise with day Regulatory compliance group in driving & sustaining ‘Inspection Readiness’ at an acceptable level; participate in routine auditing of areas.
• Co-ordinate and participate in 6S audits

Relationships

• Develop strong working relationships with People Team Leads, Lead Operators, Operators, and contribute to enhancing the direct relationship on site
• Communicate and update the People Team Lead and shift regularly (e.g. compliance issues, investigation outcomes etc)
• Developing an effective working relationship with the Area Lead colleagues and day support personnel
• Liaise and build working relationships with Quality and other support departments to resolve technical issues post event by identifying and closing out corrective actions

Flexibility

• Willingness to change shifts, and flexibility to support the business needs of both Platforms are a requirement of the role.
• Compliance Area Lead will be required to carry out any other duties as requested by their manager/People Team Lead

DISCLAIMER: This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the job. While this is intended to be an accurate reflection of the current job, Management reserves the right to revise the job or to require that other or different tasks be performed as assigned.

PRINCIPAL QUALIFICATIONS/SKILLS AND WORK EXPERIENCE REQUIRED:

• HETAC Level 7 qualification in a relevant discipline
• Excellent analytical and communication skills
• Good analytical, investigative and technical writing skills
• Good Communication skills
• Appropriate technical skills and industry sector experience desirable

Interested candidates should send their CV to Audrey.mccarthy@qaresources.com