Validation Mgr - Cleaning & SIP
Posted on Nov 23, 2019 by Anonymous
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