New job Senior Quality Project Leaders-Phila Area

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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Senior Quality Project Leaders-Phila Area Robert Ciociola posted a job: Senior Quality Project Leaders-Phila Area "Contract Position-12 Months Send resumes to: bciociola@covexllc.com CONTEXT A company in the Philadelphia area is in need of TWO Quality Project Leaders for a Pharmaceutical Manufacturing GMP Certification Readiness. The Consultants must have 10+ years of experience in the Pharmaceutical Industry preferably in Quality Audits and Compliance. DESCRIPTION This is 12 month assignment. · Experience with handling regulatory inspections, inspection readiness, preparation and review of evidence and supporting documents for regulatory commitments required, and Consent decree experience preferred. · Be able to support all Compliance functions in absence of the Compliance Head. · Strong background in managing large volume of documents and capital projects. · Must have experience in working with cross-functional project teams and interacting with internal customers and stakeholders. · Hands on experience in facilitating internal audits, tracking of audit requests, performing the duties of a scribe, a runner as necessary during audits and inspections. · Quick learner with regards to tracking and document management systems and be able to use electronic systems for document staging ROLES and RESPONSIBILITIES · Serves as primary lead for The Manufacturing Plant GMP Certification Readiness throughout the duration of the project · Works closely with other Project Managers on the Commissioning, Qualification and Validation team to keep the Certification Readiness project on time and budget · Ensures readiness and timely scheduling of the Stage Gate Verifications · Assists in all aspects of Stage Gate Verifications. · Responsible for coordinating reviews of project deliverables, document staging, and audit facilitation. · Escalates issues/potential delays related Stage Gate verifications to senior management"

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