Manufacturing Quality Assurance

Description

• 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