Full-timeHealthcare & care· Posted 25 Aug

Quality Assurance Operational Support

SanofiFrom company site

Salary

Not stated by the company

When

Office hours weekdays; 12-hour rotating shifts including day/night and weekends as required

Where

Tuas

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Start: Not stated
Work mode: On-site
Experience: Some experience

About the role

This role provides quality oversight and advice to GMP operations teams at a new Tuas manufacturing site, partnering with manufacturing, facilities, QC and technical units to keep operations compliant and efficient. It suits someone with several years of pharmaceutical or biotech quality experience who is comfortable solving complex problems and working both office hours and rotating shifts.

What you'll do

Review and approve engineering documents tied to GMP operations

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Support Installation and Operational Qualification activities for GMP equipment

Review and approve operational and process documents such as work instructions, SOPs and batch records

Support digital and automation infrastructure setup, including Delta V recipes, MES workflows, process equipment systems and ERP module setup

Help implement quality procedures and infrastructure ahead of engineering and PPQ runs

Give direct quality advice to GMP operational teams to ensure compliance, reliability and efficiency

Provide QA oversight for GMP operations, including on-the-floor oversight, raw materials and Drug Substance Intermediate release, deviations, change controls and CAPAs

Triage and resolve on-the-floor issues and take part in root cause investigations

Escalate significant quality issues to quality management promptly

Promote a strong quality culture within the operations team

Lead and support site QA continuous improvement initiatives during routine operations

Take part in regulatory inspections and interact with inspectors where applicable

Lead and support QA operations training and coaching for the quality organisation

Contribute to the site's quality manufacturing 4.0 ambition through a quality plan

Good to know

Office hours on weekdays at the Sanofi site office for collaboration and meetings leading up to engineering runs
12-hour rotating shifts including day and night and weekends on site to support PPQ, engineering runs and production activities
Based in Tuas, Singapore

Requirements

Bachelor's or Master's degree in sciences, engineering or a related technical field
At least 4 years of relevant experience, preferably in manufacturing, validation, engineering or quality in pharma or biotech
Manufacturing 4.0 mindset such as Agile methodology
Expert knowledge of pharmaceutical regulations, global quality policies and data integrity requirements
Solid technical knowledge of manufacturing processes
Broad understanding of QA operations end to end

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Quality Assurance Operational Support

About the role

What you'll do

Good to know

Requirements

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