1) General
a. Department: Quality
b. Reports to: MQA Team Leader
2) 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.
3) 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
- Execute Periodic Floor Walk
- Review Environmental Monitoring and Clean Utility Trend Control Strategies
- RSTO site Environmental Monitoring, Clean Utility Trend and Pest Control Reports approval
- Annual Audit of QC Controlled Print Documents
● Perform assigned tasks and manage competing priorities while meeting timelines to achieve company goals and department objectives
● Perform Change control assessment
● Perform Like to Like Assessments
● Notify Senior Management of potential quality, regulatory and compliance issues
● Support regulatory inspections and partner audits
● Serve as lead for Quality initiated programs
● Serve as trainer for core role specific activities
- Prepare training materials and conduct training on MQA-related procedures and processes as required
● Work alongside MQA Supervisor/ Manager in the following manner:
- Foster positive team environment by being inclusive while appreciating individualism
- Represent MQA in cross-functional meetings and discussions
- Serve as MQA subject matter expert (SME) during HA audits
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.
4) Qualifications
· Degree in Life Sciences or Engineering discipline or equivalent
· 1 to 5 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 preferred
· Good knowledge of quality systems and QA principles, practices and standards for the pharmaceutical industry
· Strong knowledge of cGMP and GDP relevant to the pharmaceutical industry
· Able to make sound decisions on quality matters
· Demonstrated excellent organizational and planning skills in managing priorities
· Meticulous, systematic and of an analytical mind
· Good interpersonal, oral and written communication skill
· Proactive team player
· Proven ability to work well under pressure
· Flexible in work hours (including shift work) to meet business objectives
