该职位来源于猎聘 Job Summary: We are seeking a highly skilled and experienced Compliance Engineer to join our team. The successful candidate will be responsible for ensuring that computerized systems and software applications used in the Quasar comply with regulatory requirements and industry's best practices. This role will play a key role in validating and maintaining the integrity of our computerized systems, while ensuring adherence to GxP practices and agencies regulations. Responsibilities:
- Validation Strategy Development: Develop and implement comprehensive validation strategies for computerized systems, including software, hardware, and associated equipment, in accordance with regulatory guidelines (e.g., FDA, EMA, NMPA etc.).
- Validation Documentation Management: Generate, review, and approve validation documentation, including but not limited to validation plans, protocols, risk assessments, and reports, ensuring completeness, accuracy, and compliance with regulatory requirements.
- Execution of Validation Activities: Lead and/or participate in validation activities such as installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and requalification, ensuring adherence to established procedures and timelines.
- Change Control Management: Assess and manage the impact of changes to computerized systems through change control processes, including evaluating change requests, performing impact assessments, and updating validation documentation as necessary.
- Risk Management: Conduct risk assessments for computerized systems to identify and mitigate potential risks to data integrity, system functionality, and regulatory compliance.
- Quality Oversight: Collaborate with cross-functional teams, including quality, engineering, and manufacturing etc., to ensure alignment of validation activities with quality management systems and regulatory requirements.
- Training and Guidance: Provide training and guidance to stakeholders on CSV principles, procedures, and best practices to enhance overall compliance awareness and competency within the organization.
- Continuous Improvement: Proactively identify opportunities for process improvements and efficiency enhancements in validation activities, driving continuous improvement initiatives to optimize CSV processes and systems.
- Stay current with industry trends, regulations, and advancements in CSV practices. Requirements:
- Bachelor's degree in a related field (Computer Science, Engineering, or equivalent).
- Minimum of 5 years of professional experience in CSV or a related field.
- Strong understanding of GxP practices and regulatory requirements (FDA, EMA, etc.).
- Proven experience in executing IQ, OQ, and PQ activities for computerized systems.
- Solid knowledge of IT infrastructure and software development life-cycle.
- Excellent problem-solving and analytical skills.
- Attention to detail and ability to work with meticulous accuracy.
- Strong communication and interpersonal skills.
- Ability to work effectively in a team-oriented environment. Preferred Qualifications:
- Certification in CSV or related areas.
- Experience in the Medical Device Manufacturing or Life Science.