QUALITY ASSURANCE (QA) SUPERVISOR

Title : Quality Assurance (QA) Supervisor

Reports to : Quality Manager or Head of Quality

Department : Quality Assurance

Responsibilities :

• Oversee Quality Systems Modules for compliance (Change Controls, Deviations, Discrepant Materials, Returns, Supplier Issues, etc.
• Support Investigations (e.g. non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups).
• Train and supervise document control / review personnel; batch release personnel, accurate record of approved, quarantined, rejected products.
• Lead the review, release and compliance of materials, FG, bulk and intermediates where applicable, to support customer requirements.
• Support audits, inspections and ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, HC, EPA, OSHA, ISO 13485 : 2016).
• Familiar with US FDA OTC drug regulations, including data integrity requirements.
• Maintains a working knowledge of QA inspection requirements for components, raw materials, in-process / bulk and finished goods.
• Ensures that review of in-process activities in both Manufacturing and Warehouse areas is conducted by QA inspectors for conformance to specifications; follow up on out-of-specifications including non conformances.
• Participates in In-process Quality in-house and outside training program.
• Conducts periodic analysis of In-process Inspection program for pre-weigh and bulk manufacture and makes recommendations.
• Assist in interpreting and / or developing of customer specifications and requirements for approved formulas.
• Assist in establishing production and assembly inspection information sheets and documentation as required.
• Maintains and updates ERP System, maintains repository of batch records / documents, and other Mfg & Assembly in-process Specifications.
• Reviews of batch records, work sheets, and Inspection documentation for completeness and correctness.
• Support non-conformance resolutions, complaint investigations, and associated corrective and preventative actions.
• Reviews of QA Inspection reports daily for correctness and completeness.
• Facilitates on site customer inspections, coordinating availability of product and communication of disposition to Quality and Inventory Control. Interfaces with customer distribution operations where needed.
• Maintains awareness and compliance with safety regulations in performing job duties.
• Ensure that finished goods, bulk, raw materials, components are maintained correctly in the warehouse and other holding areas.
• Assist in the review and release of bulk and finished products, when applicable.
• Perform supplier and vendor audits, as well as, Mock recall and internal audits.
• Support Process Validation and Cleaning & Sanitization Validation activities under the quality systems to ensure compliance.
• Support formal drug stability program, bulk hold studies, and product compatibility by co-ordinating samples submission, testing, result retrieval and program review.
• Maintains files and database of customer-approvals and documents as evidence of authenticity.
• Effects changes to specification sheets as approved through proper change control requests.
• Support Change Control Requests for Customer requested changes to raw material, intermediate / bulk, FGs, specifications.
• Maintains copies of approved change controls as applicable to product specification updates / revisions.
• Under the supervision of Quality Manager, review and approved formulas, specifications and procedures.
• Communicates new and updated SOPs to all employees at EWL.

Requirements

Benefits