CSV Engineer

3 weeks ago

Singapur, Singapore Amaris Consulting Full time
Job description

You will be responsible for ensure computerized systems, software, and technology used in pharmaceutical manufacturing, laboratory processes, and quality control comply with regulatory requirements and standards. Your role is crucial in maintaining data integrity, product quality, and regulatory compliance.

Key Responsibilities:

  • Validation Planning: Develop and implement CSV strategy and validation plans for computerized systems, including Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), Electronic Batch Records (eBR), and other relevant software.

  • Validation Documentation: Create and review validation documentation, including validation protocols, test scripts, and traceability matrices.

  • Testing and Execution: Execute validation protocols and test scripts, documenting test results, deviations, and issues. Perform functional testing, security testing, and data integrity checks.

  • Change Control and Documentation: Implement and manage change control processes for computerized systems, including assessing the impact of changes on validated systems.

  • Data Integrity: Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.

Qualifications :

  • Bachelor's degree in computer science, engineering, pharmaceutical sciences, or a related field.
  • Strong knowledge of pharmaceutical regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and quality standards (GMP, GLP).
  • Experience in computer systems validation within the pharmaceutical industry.
  • Proficiency in validation tools, methodologies, and validation testing techniques.
  • Familiarity with software development life cycle (SDLC) processes and methodologies.
  • Excellent project management skills and attention to detail.
  • Effective communication and collaboration skills.
  • Knowledge of data integrity principles and security best practices.
  • Experience with regulatory audits and inspections is a plus.

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