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Quality Manager, Process QM - Oferta z Jobs.pl

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Quality Manager, Process QM

Nr ref.: /JOBS.pl

  • There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?That's PAREXEL. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.Key Accountabilities? Identify process improvement opportunities and champion their implementation, as assigned.? Work independently and provide expert advice to groups within the organization.? Provide mentoring, leadership, direction and training to new and existing (Senior) Quality Specialists.? Participate in SOP and process development as assigned.? Participate in development of quality-related processes and tools.? Provide quality consultancy to Functional Leads, Line Manager and/or Project Leader/project leadership).Accountabilities as Head of QC in depots/warehouses:? May execute QC checks of Medicinal Products and other quality critical Clinical Trial Materials during receipt, production and distribution? Oversee all Quality Control activities in local depot/warehouse? Instruct and train QC staff and other depot staff as needed? Perform QC release of Medicinal Product batches and batches of other quality critical Clinical Trial Materials (CTM)? Oversee premise and equipment (P&E) maintenance and cleaning? Approve Product Specifications and Master Batch Records? Review and approve Production Batch Records and Test Records? Perform and support P&E qualification/validation activities as appropriate? Undertake local P&E Quality tasks as defined in PAREXEL procedures to cover local QA tasks? Oversee local depot and production (D&P) related change control procedures and quality issue (QI) reporting? Closely co-operate with local Head of Production, (Sr.) Depot Coordinator and local QP (Qualified Person) or local RP (Responsible Pharmacist) to ensure smooth depot/warehouse operations? Closely co-operate with (Sr.) GMP Lead to ensure worldwide harmonization? Work with the relevant training functions including PAREXEL Academy/Learning & Development and Operations. Assist with the development or enhancement of training materials, as assigned.? Complete or oversee the completion of assigned quality interventions/targeted/independent quality assessments. Verify compliance with GxP guidelines, local regulations, protocol, PAREXEL procedures and/or sponsor requirements.? Develop designated operational group(s) specific interventions/targeted/independent quality assessments as assigned.? Provide audit and inspection support as assigned. This may include: providing assistance/advice for audit/inspection preparation; representing Quality Management in audits and inspections asrequired; reviewing assigned audit/inspection responses. Request audits of investigational sites, local offices or processes as needed.? Provide support for management of quality issues. Facilitate and advise on corrections and corrective actions related to designated quality issues. Develop preventive actions and ensure resolution by Operational or Line Management staff, or Quality Management. Facilitate local compliance to the corrective and preventive action (CAPA) program.? Attend (or where required, lead) internal quality-focused meetings.? Maintain a familiarity with PAREXEL project-related systems and related processes.? Perform other assigned process, quality or training related tasks for particular workgroups (e.g. Line Managers, Leads) or project teams as assigned.? Remain informed about developments in relevant regulations and guidelines.? Share information in an open, balanced and objective manner with other Quality Management and other PAREXEL professionals to maintain positive, results-oriented team environment.? Deputize for manager as assigned.? International travel required of approx. 10%? Relevant experience in the Clinical Research field (pharmaceutical industry or CRO), clinical or medical experience or other relevant experience in the areas Clinical Logistics Services QM support required? Aseptic manufacturing experience required.? Knowledge of GMP regulations required? Experience of working in a GxP regulated, global environment with focus on GMP required? Leadership/project management/technology/business operations experience, as appropriate, preferred? Training experience, as appropriate, required? Relevant experience in Quality Management preferred


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