Deputy RP / QA Specialist
Position: Full time
Open date: Aug 6, 2019
Functional area: Quality
Required degrees: Masters
The job exists within the commercial Rx Local Operating Company to ensure that the mandated GSK Quality Management Systems requirements for commercial operating units are met. The function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance. The job holder is expected to support implementation of GMP and GDP requirements and sustaining the QMS on behalf of GlaxoSmithKline AG (GSK) and ViiV Healthcare GmbH (ViiV) including encouraging the Commercial Rx business to own quality activities in their day to day work.
• Ensures appropriate procedures and handling of medicinal products in compliance with regulations and local law according to Medicinal Products Licensing Ordinance (MPLO, SR 812.212.1) art. 4, art. 5, art. 7, art. 13, art. 15, art. 16 and art. 17.
• Ensures that medicinal products and medical devices for the companies GSK and ViiV HC as Marketing Authorisation Holders are manufactured, imported, released, stored and distributed in Switzerland according to GMP, GDP and local regulatory requirements. Ensures that release documentation is archived accordingly.
• Takes decision about batch release or rejection independently from local business management.
• Co-ordination and oversite of GDP and quality-related processes of the external pre-wholesaler.
• Technical evaluation of product complaints. Responsible for complaint handling with customers, manufacturing sites and Pharmacovigilance.
• Supports implementation and maintenance of the Quality Management System in the local operating company.
• Performance of self-inspections and audits.
• Responsible for management of repacking activities.
• Review and approval of Quality Agreements.
• Responsible for qualification of GMP/GDP suppliers and customers.
• 2 years of experience in GMP/GDP environment
• University degree as a pharmacist or in the area of natural sciences
• Professional written and verbal communication skills. Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization
• Ability to influence and motivate stakeholders at any level of the LOC organization
• Analytical mind, good attention to detail and problem solving skills within a structured process
• Good team player - works well in cross-functional teams
• Good time management skills, with ability to multi-task and work under pressure
• Ability to self-motivate and be resilient and focused under pressure
• Able to effectively enable and drive change across cross functional stakeholders
• Strong general computer literacy with intermediate skills in Microsoft Word, Excel, Power Point and Outlook
• Language skills: German - fluent; English - fluent; ideal - French: good command
• Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurized
• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
• Flexible thinking - able to challenge and see views from different perspectives
GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
You may apply for this position online by selecting the Apply now button.
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