What are the responsibilities and job description for the QS Associate - Line Auditor position at Accupac?
Description
Essential Functions of the Job :
- Manage the Annual Drug Product Review (ADPR) process.
- Support the Change Control process including initiation, approvals, and closure.
- Initiate and participate in investigations (including Laboratory Investigations).
- Manage the CAPA process including initiation, closure and performance of Effectiveness Checks.
- Ensure compliance to cGMP standards in the Manufacturing and Packaging areas.
- Perform Production line inspections.
- Issue and perform review of logbooks and notebooks. Perform daily calibration checks of packaging equipment.
- Perform daily checks of temperature monitoring units and notification to management / facilities of excursions.
- Reconcile staged components with approved bill of materials.
- Sample, inspect, and approve customer and vendor components.
- Sample, identify, and submit customer and vendor raw materials to the lab for testing.
- Perform all required testing at established frequency.
- Record all test and inspection results immediately and accurately.
- Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories.
- Draft, review and approve component MARS, manufacturing batch records, and packaging batch records.
- Review and approve batch records for release of customer product.
- Resolve any documentation discrepancies related to assigned tasks.
- Update paper and electronic records.
- File and archive documentation.
Perform other duties as assigned.
Minimum Requirements of the Job :
Physical Requirements :
Supervisory Responsibilities : No
Travel : None
Education and / or Experience : The QA Associate I must have a college degree and 0-2 years of Quality Control / Assurance experience in related field and LIMS experience. The QA Associate II must have a college degree, 2 plus years of Quality Control / Assurance experience in a related field and LIMS experience.
INDOTHER2024
Required Skills
Minimum Requirements of the Job :
Maintain training at or above 90% of assigned curriculum.
Ability to work individually and in groups.
