Quality Compliance Expert

**Job Description**

• The Compliance Specialist is a crucial role within the organization, responsible for ensuring adherence to Good Manufacturing Practices (GMP) and other regulatory requirements.

This involves conducting internal and external audits, managing complaints and Corrective Actions Preventive (CAPA), and supporting inspection readiness.

• Conduct surveillance audits to ensure site inspection readiness
• Coordinate self-inspections of facilities, operations, and procedures to assure conformance with GMPs and related regulatory requirements
• Interface with production, supply chain, and external customers to ensure efficient operational processes and timely CAPA closure
• Provide relevant supports during internal audits and regulatory inspections, manage follow-up on audit and inspection findingsGMP Compliance
  • Ensure compliance to relevant regulatory requirements and international standards in operations with adherence to GMP through identifying, assessing, and escalating potential compliance/quality risks
  • Coordinates site quality alerts/recalls in a 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 completenessComplaint And CAPA Management
    • Manage complaint by ensuring that investigation and corrective/preventive action are performed in a prompt manner
    • Supports the implementation and maintenance of complaint management process
    • Assist in 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
    • Assists in investigations into product complaints, including root cause analysis and corrective actions
    • Coordinates site complaint investigations by ensuring thorough root cause analysis and implementing CAPA
    • Analyzes complaint data to identify trends and potential areas for product improvement
    • Manages CAPA to address compliance incidents and prevent recurrenceSupplier Management
      • Provide quality oversight to suppliers, service providers, contracted manufacturers in areas of supplier and contractor qualification and audit GMP compliance, deviation, and change control management
      • Involves in supplier audits by ensuring compliance with the Sanofi supplier management program
      • Evaluates and qualifies new third-party vendors based on quality systems, capabilities, performance history, and compliance to relevant legal and regulatory requirements
      • Good documentation and record-keeping of third-party quality activities and communications
      • Develops and maintains quality agreements and technical specifications with third parties outlining quality expectations and responsibilities
      • Identifies and mitigated risks associated with third-party vendors through risk assessments and implementation of corrective actionsDocumentation And Reporting
        • Drafting, reviewing, and updating procedures as well as generating reports and metrics related to compliance activitiesEstablishes and monitors monthly KPI for monitoring and reportingWork Environment
          • This role is based at our Jurong API facility in Tuas (Gul Circle), Singapore, requiring full-time presence on-siteThe 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 excellenceRequired Skills and Qualifications
            • You hold an engineering/science degree or equivalent from a 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 experienceExperience in internal audits and external inspections will be preferred
            • A quick learner with a proactive 'can-do' attitudeAdaptable and flexible in managing rapidly changing priorities, with a commitment to supporting site activities with alignment to the manufacturing schedule
            • Exceptional time management skills with strong attention to detailHigh adaptability and ability to work independently and write/review reportsStrong interpersonal relationships in establishing good partnerships with cross-functional teamsGood verbal and written communication skillsEffective communication and presentation skills and a team player

              About You

              • Excellent problem-solving skills with the ability to think critically and strategically
              • Strong analytical and organizational skills with the ability to prioritize tasks effectively
              • Ability to communicate complex information in a clear and concise manner
              • Proven track record of achieving results in a fast-paced environment with minimal supervision
              • Experience with quality management systems, regulations, and industry standards such as GMP and ISO 13485

                Benefits

                • Opportunity to work with a leading pharmaceutical company in the field of quality compliance
                • Collaborative and dynamic work environment with opportunities for growth and development
                • Competitive salary and benefits package with opportunities for bonuses and promotions
                • Flexible working hours with opportunities for remote work
                • Access to training and development programs to enhance your skills and knowledge

                  Others

                  • Mid-senior level position with a competitive salary and benefits package
                  • Full-time employment with opportunities for overtime
                  • Finance and sales industry with a focus on pharmaceutical manufacturing
                  • Join a dynamic and collaborative team with opportunities for growth and development
                  • Work closely with cross-functional teams to achieve business objectives
                  • Conduct regular audits and assessments to ensure compliance with regulatory requirements and industry standards
                  • Develop and implement strategies to improve quality and efficiency in manufacturing operations
                  • Collaborate with suppliers and vendors to ensure compliance with quality and regulatory requirements
                  • Participate in training and development programs to enhance your skills and knowledge
                  • Work in a fast-paced environment with minimal supervision
                  • Opportunity to contribute to the success of the company by improving quality and efficiency in manufacturing operations