QC Specialist - TnP
Singapore, SINGAPORE
Job description
The Position
Purpose
- Perform routine and ad-hoc environmental monitoring (EM) of critical utilities such as HVAC/BSC/VLFH/HLFH, water systems, compressed air/gas system and personnel monitoring
- Lab testing of EM samples in accordance with cGMP regulations and Roche/Genentech standards.
- Support manufacturing operations by timely completion of testing and disposition.
Key Responsibilities
Technical and Functional:
- Perform EM which includes HVAC/BSC/VLFH/HLFH monitoring, compressed gas, personnel monitoring, water and clean steam sampling in accordance to cGMP procedures.
- Perform testing and review of routine and non-routine environmental monitoring samples in accordance to the Standard Operating Procedures (SOP).
- Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.
- Prepare EM trend graph periodically for trend data analysis.
- Operate laboratory autoclave and EM testing equipment.
- General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab supplies, etc.
- Perform daily checks in EM LIMS to ensure all assigned EM tasks are completed and/or tested on time.
- Initiate discrepancy record for EM action excursion, adverse trend and/or discrepant event.
- Carry out assignments / projects given by Supervisor. Deliver results per plans / schedules.
- Communicate all problems / issues timely to Supervisor.
- Suggest improvements to streamline / facilitate workflows.
- Participate in internal / external audits and regulatory inspections.
- Responsible for ensuring that all training required to support / perform GMP activities are completed timely.
- Monitor and keep track of inventory stocks for laboratory consumables and items required.
- Perform sample receipt and storage of QC samples.
Leadership:
- Work co-operatively with the Head of Micro/EM and QC 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 colleagues in continued support of the Micro / EM 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.
Key Interfaces
- Other QC functions
- FEES / Utilities
- Manufacturing
- Warehouse
- Safety, Health and Environmental (SHE)
Qualifications
Education
- Bachelor’s degree in a relevant science field or equivalent
Knowledge / Skills / Competencies:
- Demonstrate good verbal and written communication skills in English
- Independent, reliable and collaborative team player
- Able to follow written procedures.
Prepared to work overtime on weekday(s), weekend and/or Public Holiday and willing to perform shift duty if required
The Career Conversion Programme (CCP) (Train-and-Place) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. This programme is jointly supported by the Workforce Singapore (WSG) and Workforce Advancement Federation (WAF).
The training programme consists of 15 months of local attachment with Roche.
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.