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Posted: Tuesday, February 6, 2018 2:41 PM

Job Description
Sr Quality Consultant of Global cGMP and Compliance Auditing
Main responsibilities:
:Design, develop and deploy inspection ready compliance program across CMO network of small and large molecule pharmaceuticals and biopharmaceutical products.
:Asses and identify gaps and manage remediation plan of each site in order to address any major deviation on their level of inspection readiness or the respective regulatory bodies based on their product portfolio
:Oversee quality and compliance activities at clients contract manufacturing organizations (CMOs).
:Plan, conduct, and closeout independent audits to assess client CMOs level of compliance with regulations, guidelines, and operating procedures and to assure that the products are manufactured under GMP and in accordance with client regulatory requirements.
:Support team in planning, scheduling, conducting, reporting and closing audit activities on client CMOs.
:Ensure audits are conducted to assess compliance with applicable
regulations/guidelines, customer requirements, SOPs and project specific
guidelines/instructions.
:Evaluate audit findings, prepare, and distribute reports to management.
:Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, policies and procedures.
:Provide consultation to CMOs and monitor interpretation of audit observations and formulation of corrective action plans.
:Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; prepare and complete action plans; identify and resolve problems; complete audits; determine system improvements; implement change.
:Ensure qualified personnel perform the audits and generate timely audit reports, and support auditees with investigations and action plans in response to the audit observations.
:Ensure timely identification and escalation of potential critical observations and compliance gaps observed during audits.
:Stay up to date with emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements.
:Ensure team is up to date with required training to support function. Manage, coordinate, and document audits as assigned.
:Ensure routine reporting of compliance and trending reports.
:Initiate and revise Quality Agreements with CMOs as required.
:Comply with all clients corporate guidelines and policies.
Qualifications

Education:
:BS degree required concentrations in Science or Engineering (chemical or mechanical engineering,
pharmacy/pharmaceutics, chemistry, biology) is required.
:Minimum 15 years applied professional work experience working in one or more of the following areas: auditing, IT systems, manufacturing operations, quality organization, supply chain, technical operations, process research or development environment.
:Prior experience in a Quality organization and prior experience managing a global program.

Required:
:Working Knowledge of all regulations; Comprehensive understanding of Quality activities and functions.
:Experienced Internal/External Auditor; Working knowledge auditing principles and the understanding of the roles and responsibility of the related function organization within.
:Ability to interpret and apply regulatory requirements and industry best practices.
:Critical thinker, detailed oriented, while overseeing multiple tasks for several projects
:Excellent investigative skills such as analytical problem solving, fish bone, root cause analysis, etc.
:Prepare and present written correspondence, reports, and materials in a clear, concise and comprehensible manner
:Ability to handle multiple tasks to meet deadlines in a dynamic environment
:Strong organizational, interpersonal and collaborative skills
:Ability to deal with pressure and provide constructive feedback
:Ability to influence management and partner effectively ac

Source: https://www.tiptopjob.com/jobs/78014153_job.asp?source=backpage


• Location: San Francisco

• Post ID: 96145667 sf
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