Qc specialist

3 weeks ago

Singapore F. Hoffmann-La Roche Gruppe Full time

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters. The Position 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. The Opportunity 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 c GMP regulations and Roche/Genentech standards. Support manufacturing operations by timely completion of testing and disposition. Technical and Functional: Perform EM which includes HVAC/BSC/VLFH/HLFH monitoring, compressed gas, personnel monitoring, water and clean steam sampling in accordance to c GMP 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 c GMP 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. Who You Are This programme is open to Singapore Citizens and Permanent Residents only, in line with the Career Conversion Programme (CCP) eligibility requirements. Ideal for individuals seeking to switch careers into the Biopharmaceuticals manufacturing industry, particularly those looking to develop their skills in validation engineer. Degree in Life Sciences or Engineering discipline or equivalent. Minimum of 2 years of working experience for degree holders or equivalent holders with combination of education and relative work experience. Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility. Good oral and written communication skills. Meticulous and Systematic. Ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule. Must be highly motivated, able to work independently as well as a Team player, with strong focus on Safety, Quality and timeline. 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. #J-18808-Ljbffr

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