Validation officer at Biomed pharmaceutical Limited
- Preparation of protocol for routine validation and performing routine validation.
- Preparation of routine validation report and reference supporting data.
- Planning of master validation plan and other ongoing non routine instruments installation projects.
- SOP revision and CAPA implementation.
- Installation and operational qualification protocol drafting.
- Coordination with cross functional group for planning of validation.
Production Technician at Biomed Pharmaceutical Limited
- Ensured compliance with safety regulations to uphold a clean, safe work environment.
- Monitored adherence to safety standards during manufacturing per CGMP and Batch Manufacturing Order.
- Performed daily cleaning of clean room and conducted thorough pre-use inspections.
- Set up and operated production equipment according to daily work orders and safety protocols.
- Collected materials from storage based on bill of materials while ensuring quality standards.
- Returned all raw materials to storage for reconciliation after completing batch production.
- Planned work assignments by analyzing worker performance, machine capacity, and potential delays.
QA-QC Executive at Alembic pharmaceutical Limited (2023-05 – 2024-06)
- Collaborated with cross-functional teams to resolve quality-related issues swiftly.
- Conducted laboratory investigations for incidents, out-of-specification results, and out-of-trend results.
- Developed hypothesis study protocols to identify root causes of lab events.
- Utilized 6M Methodology, 5 WHY analysis, Fishbone diagram, and brainstorming tools for thorough investigations.
- Compiled detailed investigation reports outlining root causes and recommended CAPA to prevent recurrence.
- Tracked records for CAPA activities and prepared closure reports accordingly.
- Created presentations for weekly and monthly meetings to communicate findings.
- Summarized data for out-of-specification, out-of-trend results, and lab incidents.
QC Analyst at Century Pharmaceutical Limited (2020-10 – 2023-04)
- Performed all tasks in the laboratory as per GMP and SOP very accurately and within the deadline.
- Receive all samples for testing from the manufacturing and vendor sites, record all entries, and keep documents updated.
- Performed analysis of raw materials, in-process samples, finished goods, and stability study samples as per the method of analysis, and recorded all performed results in the protocol, and prepared results while maintaining all documents.
- Qualification of working standards and maintained reconciliation and stock take records up to date.
- Preparation of documentation, such as the method of analysis, specifications, and SOP, as per guidelines, regulatory requirements, and in accordance with audit compliance and vendor requirements.
- Performed change control activity for any lab-related changes, such as permanent or temporary changes, and discussed them with cross-functional groups.
- Performed daily verification of lab instruments, and kept them clean. Monthly calibration of lab instruments was performed, and data was kept for reference and approval; the QA instrument calibration log was updated.
