Quality Release Manager
ICDS RECRUITMENT
Dublin City Centre
Quality Release Manager - Dublin city. The Role: As a Quality Release Manager you will be responsible for managing, developing, maintaining and implementing all quality release activity for the Dublin site. You will act as the Site Principal QP and manage the organisational development of the Dublin QP team, providing proactive leadership for the Quality Release department. You will report to the Quality Director and will be an active member of the Dublin Quality Leadership team. Key responsibilities include (but are not limited to): · You will manage quality batch documentation, reviewing and archiving. · You will be responsible for all product release management including deviation approvals. · Working with the Quality Operations Dublin and Senior Managers, managing any product recalls. · Manage and support product stability OOS/OOT data investigations. · Manage and support the annual quality product review. · Ensure all associated Standard Operating Procedures (SOP's) and Work Instructions (WI's) are in place, reviewed, updated and that they are read and understood by departments. · Provide aligned QP Support for operational production and laboratory areas. · Provide process change control support. · Promote a continuous improvement mindset and provide input and support to system, process improvements/projects. · Provide department input to process or product investigations. · Provide input and support to quality audits/inspections. · Provide quality batch /declaration information as requested and provide QP participation in Module III process. · You will drive, develop, implement and maintain GMP standards for the operational production departments to ensure regulatory compliance. · You will drive strong people management making sure to support, develop, coach and engage a team of QP's. · The Quality Release Manager is a key member of the Dublin Extended Leadership team. Qualifications & skills sought for this role: · Minimum of B.Sc Degree or equivalent third level qualification under EC directives as a Qualified person. · At least 3 years' experience in a quality or production function in the pharmaceutical industry. · Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable. · Supervisory experience, demonstrated strong change management skills & excellent people management and stakeholder management skills. · Solid understanding of LEAN, planning & standardisation. · Be innovative, by creating new & better ways for the organisation to be successful. · Have a strategic mindset, seeing ahead to future possibilities & translating them into breakthrough strategies. · Self-starter with ability to complete work independently as well as successfully lead others if needed. · A “can do” attitude and genuine enthusiasm for driving improvements. · A positive mindset of Safety First.
715 days ago