Senior Specialist QA - (Packaging)

<p>At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.</p><h3></h3><p></p><h3>The Position</h3><p><b>Your Opportunities:</b></p><p></p><p><span>1.1    Quality Oversight</span></p><p><span> </span></p><p><span>Collaborate with key stakeholders including manufacturing operations, supplier quality, quality systems and Planning; provide Quality oversight in Drug Products life cycle and the E2E packaging process.</span></p><p></p><p><span>Participate frontline QA activities in plants.</span></p><p></p><p><span>Manage of sampling process for local packaged products</span></p><p></p><p><span>Perform oversight  of stability program for local packaged products</span></p><p></p><p><span>Execution of </span><span><span>frontline QA activities in plants</span></span></p><p></p><p><span>Acknowledge the live status in production area according to the DPS and follow up with actual excursions against the DPS, identify the potential risks and escalate timely.</span></p><p></p><p><span>Join Tier meeting in production or other Tier meetings</span></p><p></p><p><span>Perform batch record review, able to find the problem in time and try to problem solving</span></p><p></p><p><span>Enabling real-time problem solving with production team</span></p><p></p><p><span> </span></p><p><span>1.2    Implement local packaging product-related batch release process</span></p><p></p><p><span>Ensure on-time batch documentation review per the requirement of Roche Timeline.</span></p><p></p><p><span>Ensure products are not sold or supplied before a QP/AP has released, each production batch is produced and controlled in accordance with the requirements of the Marketing Authorization and other regulations relevant</span></p><p></p><p><span><span> </span></span></p><p><span>1.3    Execution of API/direct materials management</span></p><p></p><p><span>Ensure on-time material batch disposition per Roche requirement</span></p><p></p><p><span>Implement oversight of material quality including Specifications, Artwork, SAP/MES master data, Change, DMS/CAPA, new material qualification, quality management etc.</span></p><p></p><p><span><span> </span></span></p><p><span>1.4    Coordination and handling for quality related issue</span></p><p><span>Support the Event&amp;CAPA&#xff1a;Be able to utilize RCA tools and can facilitate related departments to conduct discrepancy investigation, ensure the investigation completed within specified due date and supporting products release.</span></p><p></p><p><span><span>Collaborate with </span></span><span>SMEs</span><span><span> and Lead investigators to develop investigation strategies</span></span></p><p></p><p><span>Participate  Local CAPA Review Board and participate in Quality Council when needed</span></p><p></p><p><span>Support monitor investigation progress and ensure effective corrective and preventive actions are initiated and executed on time  and keep continuous improvement</span></p><p></p><p><span> </span></p><p><span>Handle Customer complaint:</span></p><p></p><p><span>Coordinate customer complaint investigation and ensure effective corrective and preventive actions are initiated and executed on time</span></p><p></p><p><span>Handle customer inquiry</span></p><p></p><p><span> </span></p><p><span>1.5    Quality system oversight</span></p><p><span>Execute QA process/documentation maintenance in a continuously compliant state and a continual state of readiness for regulatory agency inspections</span></p><p></p><p><span>Support product recall &amp; mock recall</span></p><p></p><p><span>Support manage material quality management in site</span></p><p></p><p><span>Manage repackaging of finished products and labeling management for donation products.</span></p><p></p><p><span><span> </span></span></p><p><span>1.6    Other quality related activities </span></p><p><span>Support to draft and review the local product APQR.</span></p><p></p><p><span>Involve and support the inspection by HA and Roche Global inspection.</span></p><p></p><p><span>Involve quality related projects.</span></p><p></p><p><span>Document management</span></p><p></p><p><span> </span></p><p><span>1.7    Complete other tasks assigned by senior leaders</span></p><p></p><p><span> </span></p><p><b><span>Key Interfaces </span></b></p><p><span>Manufacturing, Engineering, Local MSAT, Planning, Warehouse, Safety, Medical and Regulatory affairs</span></p><p></p><p><span>Other Quality Functions</span></p><p></p><p><span>PQS document owners/authors</span></p><p></p><p><span>Cross-site and global BPms for Customer complaint and issue management</span></p><p></p><p><span>Global Functions: Regulatory (PDR/PTR), PT Development, QPLs TPLs and GxP Supplier Management.</span></p><p></p><p></p><p><b>Who you are:</b></p><p><b><span> </span></b></p><p><b><span>Education/Qualifications</span></b></p><p><span>●      Bachelor Degree (4 years education of Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent education level)</span></p><p></p><p><span>●      Graduate or higher-level Degree is preferred</span></p><p></p><p><b><span> </span></b></p><p><b><span>Job Required Competencies</span></b></p><p><span>●      Experience (may vary depending on site size/scope)</span></p><p></p><p><span>0-2 years’ work experience in the pharmaceutical or related industry, more than 2 years work experience is preferred.</span></p><p></p><p><span> </span></p><p><span>●      Knowledge/Skills/Competencies</span></p><p></p><p><span>Good accountability of GMP understanding and implementing.</span></p><p></p><p><span>Good accountability of regulatory understanding.</span></p><p></p><p><span>Excellent case driving ability.</span></p><p></p><p><span>Well communication skill and good accountability of problem solving.</span></p><p></p><p><span>Demonstrate good verbal and written communication skills in English</span></p><p></p><p><span>Focus on value and customer </span></p><p><span>Learn for the future </span></p><p></p><p><b> </b></p><p><b> </b></p><p></p><h3>Who we are</h3><p style="text-align:left">A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.</p><p style="text-align:left"><br />Let’s build a healthier future, together.</p><p style="text-align:inherit"></p><p style="text-align:left"><b>Roche is an Equal Opportunity Employer.</b></p>