Roche Diagnostics
From Roche Diagnostics's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
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.
The Position
Purpose
Provide QA oversight for RSTO to ensure that investigational medicinal products (IMPs) and commercial medicinal products are manufactured in accordance with global Roche, Pharmaceutical Quality System (PQS) and local site requirements.
Responsible for escalation of quality issues following the criteria defined in current governing documents
Support and/or perform routine “Make, Assess, Release” operations to meet targets and timelines
Participate in the design and implementation of department and cross-functional initiatives
To undertake additional responsibilities as required by Quality Management to meet business needs.
Perform batch record, batch reports, logbook, cGMP documents and audit trail review to ensure quality of product, compliance to Roche requirements and on-time batch disposition per defined adherence to lead time
Perform the following activities with QA oversight in accordance with Health Authority, Roche site and global PQS requirements:
Provide guidance on categorization of unplanned events
GMP area, Utilities and equipment release
Review and approve discrepancies justification for resuming GMP processing.
Execute Periodic Floor Walk
Perform assigned tasks and manage competing priorities while meeting timelines to achieve company goals and department objectives
Notify Senior Management of potential quality, regulatory and compliance issues
Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.
Degree in Life Sciences or Engineering discipline or equivalent
1-3 years of related working experience for degree holders or equivalent holders with combination of education and relative work experience
Related working experience in a biotech or pharmaceutical operating environment is a plus
Good knowledge of cGMP and GDP relevant to the pharmaceutical industry
Executes defined procedures well and shows progression in performing tasks independently
Displays good level of problem solving ability and begins to offer suggestions on complex issues
Ability to prioritise, plan and manage deliverables effectively
Meticulous, systematic and of an analytical mind
Good interpersonal, oral and written communication skills
Proactive team player
Flexible in work hours (including shift work) to meet business objectives
Who we are
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.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
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Hi [Name], I just applied for the Quality Specialist Trainee - Attach & Train program role at Roche Diagnostics. My background in [your most relevant experience] lines up well with what the team is looking for. Would you be open to a quick chat, or could you point me to the right person on the team? Thank you!
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