Quality Assurance Operational Support

In this context, we are looking for Specialist II, Quality Operations for our new site based in Singapore.

Key Accountabilities

The mission described below, must be exercised in compliance with health, safety and environment of the site rules.

The Specialist II, Quality Operations will be responsible to partner with the GMP operations team to provide Quality oversight and advice for Quality on-the-floor and operations support to ensure the Tuas Singapore GMP Quality operations meets Sanofi global Quality standard requirements and fulfil the applicable regulatory expectations. The Specialist II, Quality Operations shall be experienced in solving complex problems, and strong understanding of cGMP operations and well-versed in multiple Quality systems (including exception management, change controls, deviations/CAPAs and document management system).

The incumbent will partner closely with operational teams (e.g. manufacturing, facilities, Quality control and technical units) to ensure Quality, safety, reliability, efficiencies to support Tuas Singapore GMP manufacturing operations.

During the Project Phase, the Specialist II, Quality Operations will participate in the following Engineering / Commissioning & Qualification activities:

Engineering / Commissioning & Qualification Activities (Line B)

• Review and approval of engineering documents related to GMP operations.
• Support and provide inputs to Installation, Operational Qualification (IOQ) activities for equipment used in GMP operations.
• Review and approval of operational, as well as process related documents (e.g. work instructions, SOPs, batch records).
• Support the digital and automation infrastructure setup including Delta V recipe, MES workflows, other process equipment related systems, ERP module setup, etc.
• Ensure that Quality related operational procedures and infrastructures are successfully implemented in preparation for Engineering runs and PPQ runs at the Tuas Singapore Site to support site operational readiness and success.

Provide GMP Quality Support During PPQ Runs (Line A)

• Responsible to provide direct solid Quality advice to GMP operational teams to ensure compliance, reliability and efficiencies.
• Responsible to provide direct QA oversight for all GMP operations (including on-the-floor Quality oversight, raw materials and Drug Substance Intermediate release, deviations, change controls and CAPAs) at Tuas Singapore manufacturing facility.
• Represent Quality to triage, resolve on-the-floor operations issues, and participate in root cause investigations.
• Escalate significant Quality issues to Quality management in a timely manner.
• Champion Quality within the Operations team to establish an engrained Quality culture across the organization.

Working hours –

• Personnel shall be able to work office hours (weekdays) in Sanofi Site Office to support collaborations and meetings with stakeholders leading up to Engineering runs.
• Personnel shall be able to work 12 hours rotating shift (including day/night, and weekends) on site to support PPQ runs and Engineering runs, as required.

During Routine Operations, The Specialist II, Quality Operations Shall

• Be responsible to provide direct solid Quality advice to GMP operational teams to ensure compliance, reliability and efficiencies.
• Be accountable to ensure that Quality related operational procedures and infrastructures are successfully implemented to support EVF Singapore site operational and inspection readiness and success.
• Be responsible to provide direct QA oversight for all GMP operations (including on-the-floor Quality oversight, raw materials release, deviations, change controls and CAPAs) at Tuas Singapore manufacturing facility.
• Represent Quality to triage, resolve on-the-floor operations issues, and participate in root cause investigations.
• Escalate significant Quality issues to Quality management in a timely manner.
• Champion Quality within the Operations team to establish an engrained Quality culture across the organization.
• Lead and support the site driven QA continuous improvement initiatives/activities during the routine operational phase.
• Participate in regulatory inspections and interact directly with regulatory inspectors (as applicable).
• Lead and support QA Operations related trainings and coaching for the Quality organization.
• Contribute to reach the Tuas Singapore Quality manufacturing 4.0 ambition through a Quality plan.

Working hours –

• Personnel must be able to work 12 hours rotating shift (including day/night, and weekends) on site to support production activities.

About You

Education and experience

• Bachelor’s or Master’s Degree in Sciences, engineering or other related technical field.
• Minimum of 4 years of relevant experiences preferably in Manufacturing, Validation, Engineering, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics).

Key Technical Competencies And Soft Skills

• Manufacturing 4.0 mindset (such as Agile methodology)
• Expert Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.
• Solid manufacturing process technical knowledge.
• Broad understanding of QA Operations (from an end-to-end perspective).
• Strong interpersonal skills to establish the partnerships necessary for the development of an engrained Quality culture and the correct execution in transverse.
• Ability to work independently and make quick, effective decisions under pressure.
• Discipline and assertiveness in the decision-making and execution of digital manufacturing strategy.
• Familiarity with electronic batch record (MES) and related review processes.
• Familiarity with batch release and disposition process, preferably using the SAP system.
• Proficient in QMS and Quality Risk Management Principles.
• Excellent verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management and execution levels.
• Experience in facility start-ups will be advantageous.
• Good understanding of risk-based decision framework.
• Familiar with Digital 4.0 concepts and potential applications in Quality.