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Sr Quality Assurance Product Manager (GDP/GMP, FDA, Supply Chain Location: US-CA-La Verne Jobcode: 3603753 Email Job
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Job Title - Sr Quality Assurance Product Manager (GDP/GMP, FDA, Supply Chain)Location - La Verne, CAJob Duration: 10 monthsLa Verne - On site for 3 core collaboration days minimum Description:Sr QA Manager, - Global Product Distribution & Affiliates. *Preferred Education Level: 8+ years of experience in a GDP/GMP environment related field and a BS or BA, or 6+ years of relevant experience and a MS. Experience in US market and international product distribution, to include supporting/hostingFDA and State Pharmacy Board inspections. Experience in applying QRM. Ideally will have provided QA oversight of contracted 3PL services* Performs a wide variety of activities to ensure compliance with applicableregulatory requirements as it pertains to a US and Global product distribution operation. Maintains routine programs and processes to ensure high quality products and compliance withFDA current Good Distribution Practice (GDP) and National Association or Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements. Supports Global and Regional QA teams as well as working cross-functionally withSupply Chain, Warehouse, Customer Service personnel as well as facilities, EHS and validation colleagues in all aspects ofproduct distribution. Interfaces with and provides QA oversight of contracted 3PL activities pertaining to product distribution and process performance issues. Participates in developing Standard Operating Procedures (SOPs) and other types ofdocumentation to ensure quality objectives are met. Reviews shipping records, environmental monitoring and associated data relating to product distribution activities. Hosts NAPB external audits and interacts closely with externalregulators/stakeholders. Co-hosts/supports external FDA audits and internal audit programs. Participates in the development & delivery of training programs regarding relevant to US andGlobal product Distribution. Conducts or serves as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well asChange Management related to QA Operations. Conducts gap analyses and risk assessments of processes & procedures against relevantGDP guidelines as well as corporate standards. Participate in or where relevant lead local and corporate projects and process improvement initiatives, as required. Knowledge, Experience & Behaviours: Experience in US market and international product distribution, to include supporting/hostingFDA and State Pharmacy Board inspections. Demonstrates proficiency in Good Distribution Practices (GDP), Verified-Accredited Wholesale Distributors (VAWD) andDrug Supply Chain Security Act (DSCSA) requirements. Demonstrates working knowledge with good proficiency in Microsoft Office applications. Experience in providing QA oversight of contracted 3PL activities. Resilient profile with the ability to deliver in a challenging environment. Ability to engage and manage multiple stakeholders to achieve the objective. Organised with systematic approach to prioritisation. Positive attitude Motivated to learn new skills and embrace new experiences.
Cube Hub Inc
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