Validation Mgr - Cleaning & SIP

Posted on Nov 23, 2019 by Anonymous

Sligo, Ireland
Health Care
Immediate Start
€55k - €80k Annual
Full-Time
Are you an experienced Validation professional? Do you want to work for a biotechnology company that has been consistently ranked a "Top Employer" both in Ireland and worldwide?

Our client is seeking a "QA Validation Manager -Cleaning & SIP" to join their outstanding team of dedicated and passionate professionals who are leading the way in the Pharma/Biotech industry.

Why you should apply:

* This company offers a unique opportunity for driven and ambitious candidates. They are fully committed to their award-winning approach , and offer their employees the chance to work in a fast paced, challenging, yet rewarding environment

What you will be doing:

* You will manage, develop and build a team of subject matter experts in the areas of cleaning validation and SIP validation and continuing validation.

* Day to day management of resources, planning and assigning work to Validations Specialists and/or contingent workers to meet goals and deadlines.

* Ability to manage multiple and complex validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.

* Lead technical and quality investigations.

* Collaborates with functional departments to resolve issues.

* Manage a cross-functional projects with many stakeholders

* Reviews, edits and approves change controls, SOPs, reports and other documentation

* Review and/or approve master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

* Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.

* Trains/advises less experienced Specialists.

* May present at both internal and external (regulatory) audits if required.

* Stays current with industry trends, regulatory requirement updates, and communicating same to team

* Performs other duties assigned by Management.

* Some travel may be required.

What you need to apply:

• BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; may substitute relevant experience for education.
• Previous team/people management experience essential.
• Previous cleaning validation and steam in place experience an advantage.
• Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage

Reference: 801274442

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