Address This position is responsible for ensuring that the final product observes the company’s quality standards and for the development and implementation of inspection activities, the detection and resolution of problems, and the delivery of quality product.
- Implementation of quality systems in accordance with current Good Manufacturing Practices
- Preparation & Review of Standard Operating Procedures
- Review of Change Controls proposals
- To perform CAPA management related to investigations, and to ensure effectiveness of resultant corrective and preventative actions.
- To investigate the events, Out Of Specification, Out Of Trends and non-conformances at the site and escalate the major observations to senior management.
- Internal Audit management & compliance verification.
- Review of Analytical documents, Specifications, STP(s), qualification documents of equipment’s/instruments, APQR’s
- Handling of Regulatory Inspections.
- Analyze the data to identify areas of growth & improvement.
- Monthly Quality Data presentation and metric evaluation.
- Determining Training needs for departmental personnels and identify the training requirements to meet the quality standards
- Conduct Trainings related to cGMP, Data Integrity, SOP
- Knowledge of Software’s such as Trackwise, Training Softwares, SAP, Documentation Softwares.
Should have minimum 17 years of work experience. QC and Microbiology experience candidate will be preferable.
Should be well versed in QMS systems.
