The role:
QA Resources is currently recruiting for a Quality Operations Specialist on behalf of a leading pharmaceutical company based in Cork.
This is an initial contract role.
This role reports to the Compliance Leader with a dotted Line to the People Team Lead.
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.
Education and Experience:
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 submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to ******
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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