Excellent QC Manager role available in Cork
I am delighted to see this role coming in from a well known biopharma in Cork that is undergoing a lot of expansion recently. It's never been a better time to get your foot in the door with this company.
This role resides in the overall QC function and is responsible for leading and managing the QC Technical Support team for New Product Introduction (Process & Cleaning Validation analysis), Analytical Method development, validation and transfer activities as appropriate. It also entails the provision of day to day technical support to operations for deviations, investigations, optimisation programs etc.
Specific Job Responsibilities:
- Leads the QC Technical Support team and manages a broad portfolio of projects.
- Forms part of the QC Leadership team and works closely with the QC Commercial Groups.
- Interfaces with key stakeholders locally with cross functional departments and with Analytical Operations (AO) in Foster City HQ & CTLs.
- Generation of budgets, spend reviews and resource modelling.
- Deployment of functional G&Os & facilitate periodic goal review sessions.
- Performance Management : mid year and end of year reviews.
- Team & Individual Development Planning.
- Governance of all Safety, Quality, & Delivery of programs through MDI & team meetings.
- Provision of updates and risk escalation to QC Management.
- Applies advanced level of understanding of analytical methods for solid oral dosage and biological products.
- Presents QC Technical Support Reports to auditors incl method validation, investigations reports, analytical method transfers etc
- Plans and schedules activities that support day to day business and project goals.
- Collaborates within AO & contract test labs to develop & validate methods.
- Generation, review and approval of development & validation lifecycle documentation including change controls, risk assessments, protocols, reports etc
- Collation of data and technical writing of reports.
- Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols.
- Presents results of work, interprets data, and draws conclusions.
- Works on complex problems where analysis of situations or data requires comprehensive evaluation of many factors.
- Acts as a resource for other employees within the department.
- Coaching, mentoring and knowledge transfer to junior employees.
- Manage group with multiple areas of responsibility and may lead a component of a project within the job family.
- Identifies and introduces new technology and/or methods to the organization.
- Troubleshoot instrumentation/test methods.
Typical Education & Experience
- Extensive years of experience with BA or BS degree in Chemistry or Biology or significant experience with MS degree in Chemistry or Biology.
- PhD with no post-doctoral assignment.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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