Are you a QA Project Lead with Biotech / Pharma / Medical Device experience? We have an exciting role managing the Quality Assurance for role New Product Introductions in a tabletting facitlity.
QA Project Lead - OSD NPI - Cork
Job Description:
The job holder will lead the QA element of New Product Introduction (NPI), System and Process Improvements, in conjunction with local Operations, Engineering, Site Technology, QC and Global R&D personnel.
Principal Accountabilities:
Represent Quality as part of a cross functional team to ensure delivery of projects (NPI’s and Process / Technology) with the highest level of quality, compliance, and adherence to timelines
Responsible for Quality Oversight of NPI Projects via execution of Gate Reviews which cover the status of Change Controls, Supporting Documenation (SOPs, Test Methods, Master Batch Records etc.) Risk Assessments, Suppliers, Audits, Equipment Qualification etc.
Requirements
Bachelors Degree or similar qualification in Sciences, Engineering or similar technical discipline.
Minimum 7 + years experience in a multi-faceted quality role within a regulated industry.
Experience / Knowledge of solid oral dose manufacture.
Proven ability to successfully lead and execute projects.
Proven knowledge of FDA / EMEA requirements
Excellent communication skills both oral and written. Flexible and Adaptable.
Working Knowledge of Trackwise, SAP and Documentum.
Package:
€45K - €55K based on relevant prior experience
Minimum 6 month contract - potential to extend
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail Karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
Are you a QA Project Lead with Biotech / Pharma / Medical Device experience? We have an exciting role managing the Quality Assurance for role New Product Introductions in a tabletting facitlity.
QA Project Lead - OSD NPI - Cork
Job Description:
The job holder will lead the QA element of New Product Introduction (NPI), System and Process Improvements, in conjunction with local Operations, Engineering, Site Technology, QC and Global R&D personnel.
Principal Accountabilities:
Represent Quality as part of a cross functional team to ensure delivery of projects (NPI’s and Process / Technology) with the highest level of quality, compliance, and adherence to timelines
Responsible for Quality Oversight of NPI Projects via execution of Gate Reviews which cover the status of Change Controls, Supporting Documenation (SOPs, Test Methods, Master Batch Records etc.) Risk Assessments, Suppliers, Audits, Equipment Qualification etc.
Requirements
Bachelors Degree or similar qualification in Sciences, Engineering or similar technical discipline.
Minimum 7 + years experience in a multi-faceted quality role within a regulated industry.
Experience / Knowledge of solid oral dose manufacture.
Proven ability to successfully lead and execute projects.
Proven knowledge of FDA / EMEA requirements
Excellent communication skills both oral and written. Flexible and Adaptable.
Working Knowledge of Trackwise, SAP and Documentum.
Package:
€45K - €55K based on relevant prior experience
Minimum 6 month contract - potential to extend
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail Karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
