Perform investigations of non-conformance including customer and consumer complaints and track resulting CAPA action plans.
Daily inspection of all Manufacturing lines to ensure compliance with Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOP’s). Ensure that all manufacturing specifications are correct, clear, and complete. Audit cleanliness of machinery and operators’ attire.
Sample and inspect in-process, finished products, returned, and reworked material for quality. This includes any retain sampling as per manufacturer specifications and QC sample submission. Determine final disposition on products inspected and verify information on inventory logs. Apply appropriate disposition label to the material.
Master Batch Record Control, review, distribution and label verification.
Ensure that all finished goods are identified and released according to cGMP and company SOP.
Assist in developing validation protocols (e.g. Validation Plans, Requirements, Final Reports, and Traceability Matrix) per company Policies and Procedures.
Execute approved validation protocols (e.g. IQ, OQ, PQ) and document deviations, system failures, and corrective action.
Conduct Annual Product Reviews (APR)
Conduct cGMP training and maintains training records.
Administer the cGMP compliance audit program.
Develop and maintain SOPs and forms governing areas of responsibility.
Notify and follow through with production and Quality when variations from procedures and specifications are observed. This function includes identifying non-conforming material, recording it, and distributing required documentation.
Responsible for the timely issuance, review, and approval of QC certificates, closure of Batch Records, and deviation reports.
Perform line clearance activities as required.
Track and trend relevant quality metrics including environmental monitoring data.
Provide Quality Assurance related support to various departments.
Perform calibrations of various instruments.
We are a small, homeopathic, pharmaceutical company located in Yonkers, NY. We manufacture a wide variety of products such as tablets, liquids, gels, creams, capsules, powders and pellets.