Prajjwal Shrestha
Sydney,NSW
Summary
Competent Quality Assurance Specialist with 5 years of experience in oversight of Pharmaceutical excellence. Proven record of quality leadership in all facets of production, team performance and fulfillment or delivery. Strategic in planning, implementing and improving processes and standards which generate opportunities for sustainable company growth.
Overview
9
9
years of professional experience
Work History
Senior Quality Assurance Associate
Aegros Therapeutics
Macquarie Park, NSW
06.2022 - Current
- Perform full spectrum of functions of Quality Associate role.
- Support the QA Manager in the set up and maintenance of QMS.
- Ensure QMS and operational compliance with regulatory requirements.
- Support for key QMS systems such as audits, CAPA,SOP review etc.
- Support RA activities.
- Support in developing and implementing quality strategies.
- Deviation and compliant management, Products and Materials Release, Validation and Change Control Support, New product introduction and Documentation Controls to ensure an efficient operational Quality System that assures full compliance with company policies, regulatory requirements and cGMP.
- Responsible for ensuring that material supplied is fit for purpose for customer
- Responsible for providing quality oversight for Operational activities.
- Support the QA Manager in continuous improvement projects and quality related improvement initiatives.
- Assist in Internal Audits and the review of validation reports
- Issue and review batch documentation and release of batches of Intermediate, Bulk and Finished products
- Supervise in the preparation of annual product quality reviews.
- Assisted in developing training materials related to quality assurance processes and procedures.
- Identified potential areas of improvement in existing processes related to Quality Assurance procedures.
- Developed and implemented test plans, strategies and objectives for software applications.
- Led internal audits to identify areas for improvement and ensure adherence to quality management systems.
QA/QC Officer
Contract Manufacturing and Packing Services
Smithfield , NSW
02.2020 - 11.2022
- Ensure the production operations are performed according to the appropriate instruction and supervised by qualified personnel.
- Monitor the processes to ensure safety and quality using principles of risk evaluation at all stages of operations.
- Perform In-process Quality Control of the intermediate product at all stages and report to Quality Manager if any Out of Specification (OOS) observed different than mentioned in Batch Manufacturing Record.
- Calibration of the equipment daily, weekly or monthly as per the requirement and frequent use of it as well as monitoring cool rooms.
- Performing environment monitoring including temperature humidity check, pressure differential check, allergen test, swab test.
- Inspecting the daily activity of the production operators and checking the maintenance of the department, premises and equipment.
- Giving line clearance in each step of the production of the intermediate product upto the finished good stage.
- Checking and preparation of the release of different stages of the intermediate product i.e. blending, compression, coating and packaging.
- Record keeping of the entire lifecycle of the production including the Batch Manufacturing Record issuing including reconciliation of the batch card as well as trending of it.
- Creation and updating of the Standard Operating Procedures (SOP’s).
- Assist in the carrying out internal audits for the quality assurance purposes.
- Handling of quality documentation including deviations, CAPA’s Change Control, Risk Assessments, and Root Cause Analyses.
- Maintenance of logbooks, calibration and maintenance records for all GMP equipment.
- Coordinate with Production department, commercial, warehouse department during all stages of production and dispatch of the finished good materials for the distribution.
- Assist in the routine preparation of product master instructions (Batch Manufacturing Record and Batch Packaging Record) and SOPs under professional guidance and supervision.
- Perform physical and chemical analysis of the raw materials, intermediate products and final R&D product to determine their identity, purity and strength in accordance with the established analytical procedure.
- Strong and ethical implementation of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
- Document all results accurately and efficiently including preparation of analytical reports and Certificate of Analysis.
Quality Assurance Associate
Tismor Health and Wellness Pty Ltd
Kingsgrove, NSW
11.2021 - 06.2022
- Awareness of company policies, procedures and practices
- Overall responsibility for release for supply of FG
- Assist with review of Marketing Authorisation of FG
- Carry out packaging, finished product testing and packaging materials inspection and
assess conformance to product specifications. - Accurately review QC lab raw data
- Generate Certificate of Analysis (CoA’s) and issue to customers as required
- Change the status of packaging and products in the system when necessary to
release, quarantine or reject. - Assist customer complaint investigations, quality reports and resolution of observed
issues - Assist in internal and external GMP and quality audits
- Assist in daily production quality control inspections
- General review of quality documents
- Perform environmental monitoring testing as per the schedule and SOP
- Control the stability department and finalise reports
- To maintain the laboratory work area in a clean and tidy condition. This includes equipment and maintenance
- Responsible for review and inspect final release of product
- Teamwork & commitment to support manufacturing and packaging operations to meet customer requirements
- Carrying out any lawful duties as required by management
- Cooperate with the quality team members for efficient output.
- Strictly following OHS requirements and safety procedures
- Contribute to the achievements of the department and company’s quality
objectives.
Research Assistant
ANSTO
Camperdown
01.2019 - 12.2019
- Maintained a database of all research activities conducted during the course of each project.
- Prepared comprehensive reports summarizing research findings.
- Participated in team meetings to discuss progress on ongoing projects or brainstorm ideas for future endeavors.
- Presented findings at professional conferences or seminars as required by faculty supervisors.
- Created detailed summaries of existing studies for use in further investigations.
Product Development Officer
Magnus Pharma Pvt Ltd
Kathmandu, Nepal
01.2015 - 02.2018
Education
Master of Good Manufacturing Practice - Health Science
UTS
Ultimo, NSW11.2019
Bachelor in Pharmacy - Health Science
Purbanchal University
Kathmandu, Nepal10.2014
Skills
- Problem-Solving
- Testing Documentation
- Information Sequencing
- Quality Issue Identification
- Problem Solving
- Regulator Submission Support
- Quality SOPs Development
- Attentive and Observant
- Consistent Procedure and Protocol Use
- Audit Assistance
- Materials Analysis
Timeline
Senior Quality Assurance Associate
Aegros Therapeutics
06.2022 - Current
Quality Assurance Associate
Tismor Health and Wellness Pty Ltd
11.2021 - 06.2022
QA/QC Officer
Contract Manufacturing and Packing Services
02.2020 - 11.2022
Research Assistant
ANSTO
01.2019 - 12.2019
Product Development Officer
Magnus Pharma Pvt Ltd
01.2015 - 02.2018
Master of Good Manufacturing Practice - Health Science
UTS
Bachelor in Pharmacy - Health Science
Purbanchal University
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