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

TheCareer 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