Job Reference: JO-2004-65155_1588066907
Your new role:
As a Quality Release Associate Manager you will report to the Quality Release Manager.
In summary your primary tasks will be:
- To ensure efficient and timely review and release of Finished Product batch documentation.
- To manage and coordinate release activities across all business units, including management of Tier 1 Process and escalations to Tier 2
- To report Quality Metris/KPIs to ensure OTIF and ensure right first time (RFT) improvement plans are active.
- To ensure timely execution and ownership of Batch related TCs and Deviations within Quality Release Dept.
- To coach and develop the Quality Specialists to enable good decision making occurs in real time.
- Increase efficiencies, e.g., by means of introducing capacity management through manning boards, digitalization and optimal planning.
- To set the direction for the department, drive high performance and foster an improvement culture.
- To run and be involved with improvement projects on site.
- Overall responsible for organizational development of the Dublin Quality Specialist team in consultation with immediate manager and HR.
- Lead and develop the team leaders towards a more LEAN and efficient way of working
- Work closely together with the QPs to ensure alignment on process/product investigations and follow up corrective actions.
- Be an active member in the Dublin Quality Leadership team.
What you'll need to succeed:
- Master of Science in Pharmacy, Chemistry, Chemical Engineering, Microbiology or equivalent.
- With minimum 5 years' experience in Pharma Quality Assurance and 3 years QP release (desirable). Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable.
- General management experience, demonstrated strong change management skills & excellent people management and stakeholder management skills.
- Solid understanding of LEAN, planning and standardization.
- Behavioural competences: Must be result oriented, able to set and communicate goals and expectations, be self-driven and ambitious as well as being fuelled by driving improvements.
The successful candidate will be a demonstrated self-starter with a proactive, hands-on approach, possessing excellent interpersonal, decision-making, team work, and communication skills. They will be capable of delivering to tight and often multiple deadlines in a dynamic, challenging work environment.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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