EDWIN K

• Ensured accurate test results with proper use of lab equipment and adherence to protocols.
• Prepared specimens for testing and analysis.
• Learned multiple molecular biological techniques.
• Prepared samples for centrifugation, aliquoting and preserving sample integrity.

• Mentored and coached team members on QA topics and strategies.
• Supported company in maintaining work environment focused on quality, communication, collaboration, integration, and teamwork.
• Streamlined QA processes for increased efficiency and reduced time spent on redundant tasks.
• Participated in regular meetings with cross-functional teams to discuss progress updates, communicate concerns or challenges, and ensure alignment of project goals.

Responsibilities Handled:Planning, allocation and monitoring of the document . control to the team members to ensure GMP practice.

• Preparation and review of Weekly Reports and Monthly reports for the Quality management system.
• Preparation and review of Quarterly, Half yearly Trend Reports for OOS, OOT, Deviations, and Customer complaints during the period.
• Liaison with various departments like R&D, Analytical Development, QC, Production, Corporate affairs.
• Review and release of Batch production Records.
• Online Compliance to the Non conformances raised at manufacturing area.
• Giving clearance during the Product change over for Manufacturing Equipments and Manufacturing area and releasing batches to the next stage.

Experience with regulatory audits:

• USFDA, WHO, KFDA, AGES, EDQM, PMDA, TGA, ISO & other customer audits.