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Regulatory Compliance Specialist

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Singapore VENTAS BIO PTE. LTD. Full time
Job Title: QA Production Compliance Specialist

VENTAS BIO PTE. LTD. is seeking a highly skilled QA Production Compliance Specialist to join our team. As a key member of our production team, you will be responsible for ensuring our production operations meet the highest quality and regulatory standards.

Key Responsibilities:
  • Develop and implement quality assurance policies and procedures that comply with regulatory requirements, ensuring that all aspects of the production process are covered, from raw material reception to final product release.
  • Train staff on the latest QA/RA practices, updates, and regulatory changes, designing comprehensive training modules and conducting regular training sessions to enhance staff knowledge and compliance readiness.
  • Monitor and report on the effectiveness of QA/RA policies and interventions, utilising metrics and performance indicators to assess compliance levels, identify areas for improvement, and implement corrective actions as needed.
  • Coordinate with regulatory bodies for audits and ensure timely closure of findings by leading the preparation and follow-up actions, managing communications, and maintaining constructive relationships with inspectors and regulatory officials.
  • Perform risk assessments and root cause analyses on non-compliance issues or product defects, developing preventive measures to avoid future occurrences.
  • Review and validate the process, product labels, marketing materials, and packaging to ensure compliance with regulatory standards and that all information is accurate and legally compliant.
  • Participate in product development teams to provide regulatory guidance and ensure that new products are designed with compliance in mind from the outset.
  • Manage documentation and records according to legal and regulatory requirements, overseeing the creation, storage, and retrieval of all regulatory documents to ensure audit readiness.
  • Stay abreast of changes in regulatory legislation and guidelines, analyse implications for the business, and adapt strategies and processes to maintain compliance.
Production Process:
  • Collaborate with product process engineers to optimise and validate production processes.
  • Ensure production processes adhere to quality standards and regulatory requirements.
  • Implement quality controls and conduct routine inspections to minimise production deviations.
  • Facilitate the integration of quality standards into new and existing production lines.
  • Analyse production data to identify trends and areas for improvement in quality assurance.
ERP Implementation:
  • Assist in implementing and optimising an ERP system tailored to support production and regulatory needs.
  • Ensure the ERP system aligns with QA/RA requirements and facilitates efficient data management and reporting.
  • Coordinate training sessions for production and QA/RA teams on ERP functionalities.
  • Provide ongoing support and troubleshooting for ERP system issues.
  • Liaise between IT, production, and QA/RA departments to ensure the ERP system meets all user requirements.
Qualifications:
  • Proven lab-based production process experience with a strong focus on process validation.
  • Demonstrated interest and experience in QA/RA roles.
  • Bachelor's degree in a relevant scientific or engineering field.
  • Excellent analytical, organisational, and communication skills.
  • Minimum 3 to 5 years experience.
Preferred Skills:
  • Previous experience in ERP system implementation within a production environment.
  • Familiarity with regulatory standards such as FDA, ISO and MDR etc.
  • Experience with audit management and compliance assessments.