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Job title: Compliance Specialist

• Location: Jurong, Singapore

• Hiring Manager: Quality Assurance Manager
  

About the job:

The compliance specialist is responsible for supporting quality compliance systems within Sanofi Jurong. This role involves ensuring adherence to Good Manufacturing Practices (GMP) and other regulatory requirements through various activities like internal and external audits, complaints and CAPA management, and supporting inspection readiness.

Main Accountabilities:

Inspection Readiness:

• Perform surveillance audits on site to ensure site inspection readiness.
• Coordinate and conduct self-inspections of facilities, operations and procedures to assure conformance with GMPs, and related regulatory requirements. Interface with production, supply chain and external customer to ensure efficient operational processes and timely CAPA closure.
• Supporting site's inspection readiness activities by providing relevant supports during internal audits and regulatory inspections (i.e., FDA and HAS). Manage the follow up in the event of audit and inspection findings.  

GMP Compliance:

• Ensure compliance to relevant regulatory requirements and other international standards in operations with adherence to GMP through identifying, assessing and escalating potential compliance/quality risks with appropriate mitigation actions taken.
• Coordinates site quality alerts/recalls in timely manner with effective communication.Supports investigation and reports on any compliance incidents.
• Tracks status of standard operation procedure (SOP) compliance by performing gap analysis of quality management system through global documents/standards.Maintains compliance related documentation by ensuring accuracy and completeness.

Complaint and CAPA Management:

• Manage complaint by ensuring that investigation and corrective/preventive action are performed in promptly manner.
• Supports the implementation and maintenance of complaint management process. Assists in the oversight of site complaint handling process by ensuring timely and effective resolution of product complaints. Communicates to customers on the status and resolution of the complaints. Assisting in investigations into product complaints, including root cause analysis and corrective actions.
• Coordinate site complaint investigations by ensuring thorough root cause analysis and implementing Corrective and Preventive Actions (CAPA).
• Analyses complaint data to identify trends and potential areas for product improvement. Manages CAPA to address compliance incidents and preventing recurrence.

Supplier Management:

• Provide quality oversight to suppliers, service provider, contracted manufacturers in areas of supplier and contractor qualification and audit GMP compliance, deviation and change control management, supplier complaints review and approve Quality/Technical Agreement with supplier, contractor and customer
• Involves in supplier audits by ensuring compliance with Sanofi supplier management program.
• Evaluate and qualify new third party (if applicable) based on quality systems, capabilities, performance history and compliance to relevant legal, regulatory requirements.
• Good documentation and record-keeping of third-party quality activities and communications.
• Develop and maintain quality agreements and technical specification with Third Parties outlining quality expectations and responsibilities.
• Identify and mitigatd risks associated with third Parties through risk assessments and implementation of corrective actions. Establishes an annual audits program of third-party facilities to assess compliance with applicable regulatory requirements (GMP / GDP) and internal documents.

Documentation and Reporting:

• Drafting, reviewing, and updating procedures, as well as generating reports and metrics related to compliance activities. Establish and monitor monthly KPI for monitoring and reporting.

Other Responsibilities:

• When required, the incumbent may be responsible for coordinating the timely completion of annual product review and regulatory submissions. Supports on the review and approval of deviation/OOS/OOT/ILI investigations Coordinates change control committee by managing topics as a SME for change control system. SAP administrator for SAP-QM module, e.g. inspection plan and CoA.

Work Environment 

• This role is based at our Jurong API facility in Tuas (Gul Circle), Singapore, requiring full-time presence on-site. The nature of manufacturing operations and the importance of face-to-face collaboration with various stakeholders necessitates working from our facility to ensure optimal team performance and operational excellence. 

About you

Experience:

• You hold an engineering/Science Degree or equivalent from recognized institution with 3-5 years of experience in quality compliance within the pharmaceutical industry or equivalent holders with a combination of education and relevant work experience. Experience in internal audits and external inspections will be preferred.
• A quick learner with a proactive ‘Can-do’ attitude. Adaptable and flexible in managing rapidly changing priorities, with a commitment in supporting site activities with alignment to the manufacturing schedule. Discipline and assertiveness in the decision-making and execution of quality related issues.
• Exceptional time management skills with strong attention to detail.
• High adaptability and ability to work independently and write/review reports. Strong interpersonal relationships in establishing good partnerships with cross functional teams.
• Good verbal and written communication skills; effective communication and presentation skills and a team player

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