• Oversee the establishment/ optimization of the Quality Manual, Quality Specifications, and Quality Management Systems
   

• Supporting clients in the development of Quality Manual, Specifications, and Quality Management System by leveraging PTSI templates.

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• EMPQ Project Management, Readiness, Scheduling, Execution, Final Report, and Supporting SOP Development.

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• Leverage our PTSI Library in customizing our clients Quality Manual, Specifications, and Quality Management System by leveraging PTSI templates.

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• Experienced Technical Writers utilizing PTSI Library in support of SOP, Commissioning, Validation, and Manufacturing Batch Record/ Sampling Plan Development.

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• Lead in the FDA/ Regulatory PAI, Biennial, QP Certification, and Inspection Readiness/ Remediation execution.

• QA CMO PIP review/ approval of Manufacturing Batch Records, Deviations, OOS’s, Change Controls, EM Excursions, CAPA, SOP’s, and Validation Protocols.

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• Establish Commissioning/ Validation Master Plans and oversee Implementation.

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• Provide experienced Quality and Quality Control SME’s.