SGP
1 day ago
QC Associate (System)
**About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. **Main Responsibilities** 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 at Sanofi (Aventis-Pharma). Only candidates eligible for CCP programme may apply. + Updating the site validation master plan and procedures related to ALCM and CPV of GXP lab equipment. + Support periodic analytical method control trend review/ investigation and data evaluation on method performance, recommend method improvements where appropriate. + Support the life cycle management of the QC lab equipment i.e qualification of QC equipment and periodic review are maintained for their intended use. + Maintaining up to date the lab equipment inventory. + Participate in proper documentation issuance and review of qualification and maintenance deliverables, such as risk assessments, traceability matrices, protocols, reports, deviations, and summary reports. + Support laboratory qualification Investigation and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs. + Providing support during regulatory inspections and audits. + Prepare metrics and monitoring data for the qualification and validation activities, to identify trends and issues, during life cycle management of QC laboratory equipment. + Support initiatives for continuous improvement in QC support processes related to lab equipment management in coordination with QC excellence team. + Perform periodic analytical method control trend review/ investigation and data evaluation on method performance, recommend method improvements where appropriate. + Support invalid assay trending program in the QC laboratory. + Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements. + Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records related to these tasks. **About You** + Minimum of two (2) years of experience in quality control in GMP environment with hands-on exposure and theoretical requirement of QC laboratory instruments and ALCM management. + Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology + Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements. + Proficiency in identifying issues and implementing effective solutions to resolve quality control problems. + Good understanding of good laboratory practices, good documentation practice and data integrity requirements. + Experienced in analytical method continuous monitoring requirements. + Strong interpersonal relationships to establish the partnerships necessary for the development of the Quality culture. + Independent, discipline and assertiveness in decision-making and execution in laboratory activities. + Continuous improvement mindset. + Must be highly motivated and able to work well as team player. Location: Incumbent will be based in 61 Gul Circle Singapore 629585 **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
Confirm your E-mail: Send Email
All Jobs from Sanofi Group