Responsibilities :
- Issuance and review of all Standard Operating Procedures (SOP) (new, revised and version control).
- Issuance and review of all Product Specifications and Certificates of Analysis (CoA) (new, revised and version control).
- Issuance and review of Master Batch Records (MBRs) (new, revised MBRs and version control).
- Review of all executed Batch Records.
- Review of all labels.
- Receipt and handling of all Customer Complaints, Investigations and Adverse Reaction Reporting.
- Initiating, investigating and reviewing of Deviation Investigation Reports and Corrective and Preventative Actions (CAPA) for all out of specification and non-conforming materials and processes / activities.
- Documentation and investigation of Change Control activities.
- Assisting in yearly mock recall to ensure recall procedures are accurate and compliant.
- Coordinating the sampling and testing program for all manufactured products.
- Assist in the assessment and receipt of input materials.
- Assist in the assessment and receipt of raw materials, excipients and additional manufacturing materials for production.
- Assist in the assessment and receipt of cleaning / sanitation agents.
- Review and assessment of Finished products for release.
Quality Assurance Associate
Issuance and review of all Standard Operating Procedures (SOP) (new, revised and version control).Issuance and review of all Product Specifications and Certificates of Analysis (CoA) (new, revised and version control).Issuance and review of Master Batch Records (MBRs) (new, revised MBRs and version ...
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