What are the responsibilities and job description for the Validation Associate position at Accupac?
Job Description
Job Description
Essential Functions of the Job :
- Maintain the Company’s compliance with established Accupac, LLC. Standard Operating Procedures, FDA Current Good Manufacturing Practices, and the Customer’s specifications.
- Establish performance and quality criteria. Create and run quality tests based on appropriate protocols.
- Ensure compliance with safety and quality standards.
- Strong understanding of manufacturing, packaging, and cleaning processes and safety regulations.
- Ensure products meet company requirements by writing protocols and creating a documented trail of results for both manufacturing and packaging processes.
- Strong documentation bias – managing and documenting the entire validation process. The protocols produced must comply with both internal SOPs and external regulations.
- Perform Equipment IQ / OQ and Gap analysis.
- Review all questions, errors, and deviations with the respective departmental Management and QA and resolve issues.
- Maintain the completed validation documentation and all associated data.
- Maintain open communication with Project Management and Operations for validation requirements.
- Maintain Calibration Management database including entering, changing, and updating equipment status in the Calibration Manager database.
- Provide PM and Calibration documentation to either internal or external personnel.
- Provide oversight on the timely completion of PMs and Calibrations.
- Review completed validation, PM, calibration documentation for accuracy and GMP compliance.
- Performs other related duties as required and assigned.
Minimum Requirements of the Job :
Physical Requirements :
Supervisory Responsibilities : No
Travel : None
Education and / or Experience : For a Validation Associate I a B.S College degree is preferred or a minimum of 1-2 years of experience in a cGMP regulated industry (validation experience preferred). For a Validation Associate II a B.S Degree is preferred and a minimum of 2-4 years of experience in validation in a cGMP regulated industry.
