CQV CSV Engineer (Pharma) (SG)
Date Posted: August 30, 2024
Job Description
We’re seeking a talented CQV (Commissioning, Qualification, and Validation) CSV (Computer System Validation) Engineer to join our team and play a vital role in ensuring compliance and operational excellence in our pharmaceutical facility in Singapore. As a CQV CSV Engineer, you will be responsible for commissioning, qualifying, and validating computerized systems, ensuring they meet regulatory requirements and industry standards.
Key Responsibilities
- Develop, execute, and manage commissioning, qualification, and validation (CQV) activities for computerized systems in a pharmaceutical environment.
- Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements for all computerized systems.
- Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure systems meet user requirements and functional specifications.
- Author and review validation documentation, including validation plans, protocols, and reports (e.g., URS, FRS, DQ, IQ, OQ, PQ).
- Conduct risk assessments and implement mitigation strategies to ensure system compliance and data integrity.
- Troubleshoot and resolve issues related to computerized systems, ensuring minimal disruption to operations.
- Maintain up-to-date knowledge of regulatory guidelines, such as GAMP 5, FDA 21 CFR Part 11, and EU Annex 11, to ensure systems are validated in accordance with industry standards.
Required Qualifications and Skills
- Bachelor’s or Master’s degree in Engineering, Computer Science, or a related field.
- 3-5 years of experience in CQV and CSV activities within the pharmaceutical or biotech industry.
- Strong knowledge of GMP, GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 regulatory requirements.
- Proven experience with computerized system validation (CSV) and data integrity principles.
- Excellent technical writing skills for creating and reviewing validation documentation.
- Strong analytical and problem-solving skills, with the ability to work independently and collaboratively in a team environment.
- Effective communication and interpersonal skills to interact with cross-functional teams and stakeholders.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E
