Aspire Pharma
SUMMARY:
This position is responsible for in-process quality of the product at manufacturing, bulk/finished product packaging.
EDUCATIONAL QUALIFICATION:
Minimum of Highschool diploma or relevant education; and/or minimum of two years of related experience and/or training; or equivalent combination of education and experience.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Ensure compliance with cGMP, Company SOPs and FDA requirements during all phase of operations. To perform sampling of raw materials and packaging materials as per current SOPs. Reviews incoming raw materials and packaging material documentation for completeness, accuracy and compliance according to associated SOP's. Prepares and maintains Receipt label, Release label for Raw material, Packaging materials. Performs and maintains in-house balance calibration and its log. Perform room, equipment, and manufacturing/packaging line checks (where applicable) prior to each stage of manufacturing and packaging following detailed written procedures. Conduct in-process checks as per manufacturing and packaging batch record instructions. Prepare bulk/finished product samples for QC lab and QA retains, following detailed documentation procedures. Ensure all logbooks are logbooks are completed and reviewed at manufacturing and packaging area. Performs swab analysis on specific equipment to ensure cleanliness. Performs label verification prior to start packing of finished bulk product and cleaning verification prior to use of packing area. Perform sampling for controlled sample, microbiology, validation and stability as required based on respective batch manufacturing record, batch packaging record and packaged product packaging specification. Labeling component receipt, visual examination & preliminary inspection. Preparation of labeling components inspection reports; Issuance of labeling components according to packaging order and regular monitoring and auditing of label room. Review of batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step. To perform appropriate storage, issuance, periodic visual inspection and destruction of retain samples. To train QA Inspector I. Review of executed gelatin batch records. To collect all data required for Annual Product Quality Review. Verification of functionality of all the equipment and associated controls during the batch run. Utilize various software applications using Microsoft Office, SySpro, Rite-Scan, QR Code, etc. Other duties as assigned by management.
This position is responsible for in-process quality of the product at manufacturing, bulk/finished product packaging.
EDUCATIONAL QUALIFICATION:
Minimum of Highschool diploma or relevant education; and/or minimum of two years of related experience and/or training; or equivalent combination of education and experience.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Ensure compliance with cGMP, Company SOPs and FDA requirements during all phase of operations. To perform sampling of raw materials and packaging materials as per current SOPs. Reviews incoming raw materials and packaging material documentation for completeness, accuracy and compliance according to associated SOP's. Prepares and maintains Receipt label, Release label for Raw material, Packaging materials. Performs and maintains in-house balance calibration and its log. Perform room, equipment, and manufacturing/packaging line checks (where applicable) prior to each stage of manufacturing and packaging following detailed written procedures. Conduct in-process checks as per manufacturing and packaging batch record instructions. Prepare bulk/finished product samples for QC lab and QA retains, following detailed documentation procedures. Ensure all logbooks are logbooks are completed and reviewed at manufacturing and packaging area. Performs swab analysis on specific equipment to ensure cleanliness. Performs label verification prior to start packing of finished bulk product and cleaning verification prior to use of packing area. Perform sampling for controlled sample, microbiology, validation and stability as required based on respective batch manufacturing record, batch packaging record and packaged product packaging specification. Labeling component receipt, visual examination & preliminary inspection. Preparation of labeling components inspection reports; Issuance of labeling components according to packaging order and regular monitoring and auditing of label room. Review of batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step. To perform appropriate storage, issuance, periodic visual inspection and destruction of retain samples. To train QA Inspector I. Review of executed gelatin batch records. To collect all data required for Annual Product Quality Review. Verification of functionality of all the equipment and associated controls during the batch run. Utilize various software applications using Microsoft Office, SySpro, Rite-Scan, QR Code, etc. Other duties as assigned by management.