• Ensure implementation of cGMP, GLP and GDP • Monitoring processing and laboratory activities in the facility on a daily basis • Hosting regulatory audits • Member of internal audit team • Preparation and implementation of Standard Operating Procedures, Stability Protocols, Master Batch Production Records, etc. • Evaluation and Qualification of vendors for raw materials, packaging materials and contract services • Sampling of raw/ packaging materials, in-process samples, finished products, reserve samples and stability samples • Review of analytical material release data & documents and method validation protocols and reports • Preparation and review of master and executed batch manufacturing and packaging records • Assigning of Batch Numbers for submission batches • Equipment, Area/Room line clearances for manufacturing/packaging • In-Process Quality Assurance checks during manufacturing and packaging • Monitoring of submission batches. • Collection and maintenance of stability samples and execution of stability protocols • Monitoring of stability studies • Support to Regulatory Affairs by providing the necessary documents and information for submission purposes and others if any • Submission of all necessary documents to Regulatory Affairs • Review of process deviation/ incident reports, change controls, out of specification reports • Swabbing equipment for cleaning verification • Perform documentation control checks • Issuance of item codes, labels and controlled & uncontrolled copies of documents • Storage, retrieval, control and retention of all completed documents

Highlights:

• QUALITY ASSURANCE
• QA TECNICIAN
• VALIDATION
• DOCUMENTATION
• QA AUDITOR
• BMR
• Test
• Audit
• Documentation
• Internal audit
• Manufacturing
• Microsoft
• Microsoft Office
• Packaging