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Quality Release Associate Manager

Quality & Laboratory
Therese Keohane
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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 responsibilities:

  • 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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The Life Science Specialists

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Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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