Employer Industry: Pharmaceutical Manufacturing

Why Consider this Job Opportunity:
- Competitive salary up to the industry standard
- Opportunity for career growth and advancement within the organization
- Chance to work in a highly regulated industry and gain valuable experience
- Collaborative work environment with a multi-disciplinary validation team
- Opportunity to make a positive impact on regulatory compliance and client satisfaction

What to Expect (Job Responsibilities):
- Prepare and execute test documentation for GMP computerized systems
- Troubleshoot issues during test execution
- Coordinate with the validation team to validate automated equipment and control systems
- Create and modify validation documentation, including User Requirements Specifications, CSV protocols, and reports
- Review and approve system implementation plans and summary reports

What is Required (Qualifications):
- Excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies
- Previous experience in preparing and executing test documentation for GMP computerized systems
- Strong attention to detail and problem-solving skills
- Ability to coordinate and collaborate with a multi-disciplinary team
- Proficiency in reviewing and approving technical documents

How to Stand Out (Preferred Qualifications):
- Knowledge of ALM (Application Lifecycle Management) and experience in reviewing and pre-approving test scripts
- Familiarity with regulatory risk assessment processes
- Previous experience in retirement plan review and summary

#PharmaceuticalManufacturing #ValidationDocumentation #GMPCompliance #RegulatoryCompliance #CareerGrowth

We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.