Quality Assurance Specialist - Product Release

Quality Assurance Specialist - Product ReleaseQuality Assurance Specialist - Product releaseThe primary responsibility of this position is to support the Roche Diagnostics Cape Town QMS with product/batch release activities and act as a QA partner for assigned departments.Support the Quality Assurance Operations team to develop, implement and continuously improve the current Quality Management System. Support the day-to-day administration and maintenance of Quality Assurance Operations functions at the site. Timeously review and release of product as determined by Operations.Reviews and approves critical control checklist supplied by Operation departments (Quality Control and Manufacturing) for disposition of products.Reviews and approves critical control checklist related to validation of material deemed fit for purpose. Ensures non-conforming product that is identified during batch record review is appropriately controlled. Assists with the review of corrective and preventive actions related to non-conformances raised during Manufacturing, Quality Control (QC) testing and kit packing with a direct impact on product release.Ensures that risk-associated actions identified are addressed and mitigated prior to product release.Reviews concession requests for release, rework or reprocessing and are the gatekeepers for product release risk assessment.Attends regular Operations meetings to ensure product status and priority is clearly communicated.Escalates product release concerns to the Sub-Network Lead.Assists in the review of Shipment and Warehouse temperature excursions to provide product disposition.Tracks the product release document review metrics associated with approvals, returns due to errors and rejects.Reviews and updates documentation changes in the EDMS, as appropriate.Monitor, identify and implement gaps in the QMS to continuously improve quality systems in relation to product release. Establish, nurture and maintain good working relationships with internal and external stakeholders through regular communication, networking and attending relevant meetings.Build a team culture of excellence, exceptional work ethic, superior quality of work and collaborative team spirit. Expected to operate independently, holding him/her accountable to proactively fulfil tasks and achieve results within assigned timelines.What you will bring:Bachelor's DegreeBachelors or degree in Chemistry, Biological Science, Engineering or related scientific discipline (biomedical engineering) or related biological science field, or equivalent combination of education and work-related experience in the area of product development, verification and validation, required.Masters degree in Chemistry, Biological Science, Engineering or related scientific discipline (biomedical engineering) or related biological science field would be an advantageExperienceA minimum of 2 years work experience in product release in a related industryAn equivalent combination of education and experience may be substituted for bachelor degree.Knowledge, Skills and AbilitiesDemonstrates high degree of initiative and motivation with the ability to work independently and be a self-starter.Ability to apply process and business judgment.Ability to plan and organization work while remaining flexible.Ability to communicate technical issues to management and non-technical audiences.Ability to work with cross-functional teamsDemonstrate a high degree of accuracy and qualityAbility to work under pressure and meet tight deadlinesWho we areAt Roche, more than , people across countries are pushing back the frontiers of healthcare. Working together, weve become one of the worlds leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. We believe its urgent to deliver medical solutions right now even as we develop innovations for the future. We are passionate about transforming patients lives. We are courageous in both decision and action. And we believe that good business means a better world.That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.
Cape Town, WC, ZA