Quality Assurance Specialist I
Occupations:
Quality Control AnalystsQuality Control Systems ManagersInspectors, Testers, Sorters, Samplers, and WeighersRegulatory Affairs ManagersRegulatory Affairs SpecialistsIndustries:
Pharmaceutical and Medicine ManufacturingPetroleum and Petroleum Products Merchant WholesalersLumber and Other Construction Materials Merchant WholesalersApparel, Piece Goods, and Notions Merchant WholesalersMotor Vehicle and Motor Vehicle Parts and Supplies Merchant WholesalersTechnical Job ResponsibilitiesManage required quality activities in the Clinical and Commercial PT distribution and in-country GMP/GDP operations owned by PT, including as applicable:Regulatory readiness activities required to ensure a regulatory compliant supply of clinical and commercial material, such as the quality oversight of Artworks operations; management of GMP documents required for Launches, Variations & Renewals and management of IMP Flowcharts required to ensure compliance to the respective IND/QIMPD.Quality oversight of Transportation activities including the management, resolution and Product Quality impact assessment of unplanned and planned events during transportation of clinical an commercial products.Quality oversight of Clinical and Commercial PT distribution and in-country GMP/GDP operations, taking place at Transport providers; Warehousing & distribution centers; Partners (including External Sponsors of Clinical Trials, In- / Out-Licensing Partners, Divestment Partners and Co-Promotion Partners); Local CMOs and Laboratories contracted for in-country testing activities.Customer engagement activities, including the intake and response to Customer complaints and the design and deployment of Customer-centric solutions applicable in the distribution operationsOwn, manage and build Quality capabilities within the Distribution Quality Chapter and theCountry Quality Network to meet Strategic Objectives, Customers expectations and promote a value-driven mindset.Identify and drive continuous improvements by actively scanning and keeping up to date on customers needs and expectations, regulatory requirements and industry trends and network performance results.Ensure Audit and inspection readiness in the Clinical and Commercial PT distribution and in country GMP/GDP operationsOwn, manage and drive the implementation of Quality requirements applicable to Distribution in defined within PQS, and collaborate with external stakeholders to shape and evolve the corresponding regulatory requirementsRelease, reject or quarantine clinical/IMP, commercial medicinal products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced withinthe area of responsibility per applicable Swissmedic and internal requirements on behalf of the Authorized Person (AP).Disposition (release or reject) product within the area of responsibility per applicable Roche requirements, cGMP, and the schedule. Support QP Declaration and Certification requirements.Pay Rate Range: $30-40/hr depending on experience