In Process Quality Assurance

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.