Ensuring Compliance:
Implementing and maintaining a quality management system to ensure compliance with GMP, GLP, and other relevant regulations.
Process Monitoring:
Real-time monitoring of production processes to ensure adherence to quality standards and procedures.
Quality Control:
Overseeing quality control activities, including raw material, in-process, and finished product testing.
Documentation and Record Keeping:
Maintaining accurate records of all quality-related activities, including batch records, SOPs, and validation documents.
Deviation Management:
Identifying, investigating, and resolving deviations, out-of-specification (OOS) and out-of-trend (OOT) results, and implementing corrective and preventive actions (CAPA).
Audits and Inspections:
Participating in internal and external audits and inspections to assess compliance and identify areas for improvement.
Training and Support:
Providing training to production staff on quality procedures and best practices.
Continuous Improvement:
Contributing to quality improvement initiatives and projects to enhance processes, products, and systems.
Product Release:
Reviewing and approving documentation for product release.
Change Control:
Managing and approving changes to processes, procedures, and equipment.
Complaint Handling:
Investigating and resolving customer complaints related to product quality.
Staying Updated:
Staying informed about the latest industry trends, regulatory changes, and best practices.