QC Specialist (Senior)
Singapore, SINGAPORE
Job description
The Position
QC Specialist (Senior)
*This is a Day Shift role (7.30 am - 8 pm) while the shift pattern goes by two-week cycles. E.g.
Week 1 Shift - Mon, Tue, Fri, Sat, Sun
Week 2 Shift - Wed, Thursday
Key Responsibilities
Technical and Functional:
* Testing and review of routine and non-routine product and/or in-process samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM).
* Testing, documentation, and review of results in accordance with current Good Manufacturing Practices (cGMP) and Procedures.
* Ensure timely completion of testing and reporting of test results in support of manufacturing operations.
* General lab support including housekeeping, equipment maintenance, and maintaining inventory of lab supplies.
* Author and/or update existing SOP and TM as needed.
* Train other analysts on methods and/or SOP.
* Participate/ support in QC or cross-functional projects: equipment qualification, method validation, method transfer, and process improvement projects.
* Support investigation and studies.
* Problem-solving of testing-related issues as well as troubleshooting of equipment.
* Initiator and/or lead for discrepancy and investigation record.
* Perform assessment for lab-related discrepancies and identify corrective actions where necessary.
* Work closely with network SME and actively participate in cross-functional meetings as and when required.
* Responsible for ensuring that all training required to support/ perform GMP activities is completed timely.
Leadership:
* Work co-operatively with the direct line supervisor to create an environment of strong team spirit, timely and effective communications. Strive towards team’s objectives/goals, takes the initiative and proactively turn ideas into action – to make things happen.
* Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
* Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
* A team player and the willingness to cover other shift colleagues in continued support of the In-Process Control operations.
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
Education:
* Degree/ Diploma (biochemistry, chemistry or other relevant discipline is preferred.)
* Minimum 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 preferred.
Knowledge/Skills/Competencies:
* Strong knowledge of analytical, biochemistry laboratory operations in support of commercial manufacturing
* Knowledge of cGMP relevant to the pharmaceutical industry
* Knowledge of laboratory safety procedures
* Knowledge of Quality System principles, practices and standards for the pharmaceutical industry
* Demonstrate excellent verbal and written communication skills in English
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.