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The Position
General
Department: Quality
Reports to: Head of MQA & QATS
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.
Key Responsibilities
Technical and Functional:
- 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
Safety, Health & Environment:
- 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.
Lean Production System:
- 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.
Qualifications
- 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
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.