Quality Assurance:
- Ensures that manufacturing processes and products comply with regulatory guidelines and industry standards.
- Reviews and approves documentation related to manufacturing and quality control.
- Conducts audits and inspections to verify compliance.
- Participates in the investigation of deviations and complaints.
- Develops and implements quality assurance procedures.
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Quality Control:
- May be involved in sampling and analysis of raw materials, in-process materials, and finished products.
- Performs tests using various analytical techniques (e.g., titration, chromatography, spectrophotometry).
- Reviews and validates test results and raw data.
- Maintains and calibrates laboratory equipment.
- Prepares and/or reviews SOPs (Standard Operating Procedures) and protocols.
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Compliance:
- Ensures compliance with cGMP (Current Valuable Manufacturing Practices) and other relevant regulations.
- Maintains accurate records of testing and quality control activities.
- May be involved in the preparation and review of regulatory submissions (e.g., NDAs, ANDAs).