Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Parth Usdadiya

Auckland,AUK

Summary

Results-driven Quality Team Lead with 13 years of experience in the pharmaceutical industry. Strong background in pharmacy with career progression from Quality Control Technician to Medical Representative, QA Officer, Chemistry Technician, Quality Representative and Quality Associate. Proven track record in ensuring regulatory compliance, driving quality improvement, and optimizing operational efficiency. Skilled in leading cross-functional teams and fostering a culture of quality. Deep understanding of pharmaceutical manufacturing processes and regulatory guidelines.

Overview

12
12
years of professional experience
1
1
Certification

Work History

QUALITY ASSOCIATE - RELEASER

Slade Health Ltd
09.2023 - Current
  • Collect ingredients for batches and complete associated documentation
  • Decontaminate assembled batches and distribute to the various cleanrooms
  • Check volumes, reconcile labels and package the final products
  • Act as an Authorised Person (AP) to Release or reject final product, where trained and approved to do so
  • Ensure final product and associated documentation are fit for Release according to GMP standards
  • Ensure all batches are admixed according to the customer order
  • Release admixed products as per relevant Standard Operating Procedures/Work Instruction
  • Store Released products in the correct storage environment to maintain stability
  • Ensure all products are compounded appropriately according to product specifications and documentation to obtain the required quality
  • Participate in Change Control activities
  • Ensure all product non-conformances are evaluated and rejected and/or escalated to quality management (where required) in a timely manner
  • Ensure all incidents, deviations (planned and unplanned) and complaints are reported to the appropriate persons and documented in the QMS in a timely fashion
  • Environmental Monitoring & Control Co-ordinate environmental monitoring of cleanrooms: Ensure all microbial sampling is completed as required
  • Ensure all particulate sampling is completed as required
  • Review and finalise environmental monitoring results: Read all incubated micro plates, complete relevant records, update registers, complete OOS investigations where required
  • Review all portable particle monitoring results, complete relevant records, update registers, complete OOS investigations where required
  • Monitor environmental monitoring systems, complete OOS investigations where required
  • Maintain and organise the site micro laboratory
  • Co-ordinate cytotoxic residue monitoring of cleanrooms
  • Ensure environmental monitoring equipment remains in working order and in calibration
  • Order entry of media fill and stock batches.

QUALITY TEAM LEADER

iMIX Ltd
02.2023 - 09.2023
  • Lead and supervise a team of quality assurance professionals
  • Ensure adherence to regulatory requirements and good manufacturing practices (GMP) throughout the organization
  • Develop and maintain quality management systems (QMS) to support effective quality control and quality assurance processes
  • Implement and monitor standard operating procedures (SOPs) for quality control and quality assurance activities
  • Collaborate with cross-functional teams to resolve quality-related issues and implement corrective and preventive actions (CAPA) as needed
  • Oversee the review and approval of documentation, including batch records, change controls, deviations, and non-conformance reports (NCR)
  • Drive continuous improvement initiatives to enhance quality processes, reduce defects, and optimize operational efficiency
  • Collaborate with senior management to establish quality goals, metrics, and strategies to achieve operational excellence.

QUALITY REPRESENTATIVE

Imix Ltd.
12.2021 - 02.2023
  • Review patient orders, calculate and verify doses against order sheets
  • Release aseptically manufactured finished products in accordance with established protocols
  • Conduct quality control checks on compounded items
  • Make decisions on product rejection based on quality framework guidelines, such as strands/filtering
  • Check and review documentation, as well as write and update SOPs as required
  • Assist in reviewing incoming goods to iMIX and reprocessed aseptically compounded products
  • Perform daily environmental monitoring (EM) tasks for all sessions, including Cytotoxic, aseptic, and clean rooms
  • Maintain temperature records for fridges and freezers, recording readings daily
  • Provide support for sampling activities as needed or requested
  • Help resolve quality-related issues that may arise during the aseptic compounding process
  • Support the QA Team Leader in raising and processing CAPA (Corrective and Preventive Actions), NCR (Non- Conformance Reports), Change Control, and Deviations.

CHEMISTRY TECHNICIAN

GMP Pharmaceuticals Ltd
09.2019 - 12.2021
  • Conduct physical and wet chemistry tests on raw materials, including weight, friability, hardness, disintegration, Karl Fischer titration, loss on drying, water activity, UV, and FTIR
  • Prepare materials for experimentation, freezing, slicing specimens, and mixing chemicals
  • Monitor temperature, humidity, and calibrate and use the pH meter
  • Collect, test, and analyze incoming raw materials and bulk products according to standard procedures, ensuring accurate documentation and maintaining a neat and orderly work area
  • Control the quality and quantity of laboratory supplies, check and maintain testing equipment, and ensure availability and proper use of test methods and standards
  • Conduct stability testing, sampling, and release of packaging materials
  • Preserve retention samples, compare test results with reference standards, and maintain accurate records of testing activities and environmental conditions.

QA OFFICER

GMP Pharmaceuticals Ltd
07.2018 - 08.2019
  • Develop master formulations, specifications, and labeling/packaging checks
  • Perform production checks, including start-up and in-line inspections
  • Organize and maintain samples of raw materials and finished products for customers
  • Provide technical documentation, manufacturing contracts, and SOPs to customers
  • Assist with formulation development, vendor assessment, and problem-solving
  • Conduct monthly calibration of critical instruments and perform internal audits
  • Support product investigations, check and release bulk/finished products, and contribute to other projects as directed by senior management.

MEDICAL REPERESEANTATIVE

CACHET PHARMACEUTICALS PVT LTD
08.2012 - 10.2015
  • Arrange appointments with doctors, pharmacists, and hospital medical teams, including presentations in medical settings and conferences
  • Build and maintain positive relationships with medical staff and administrative personnel
  • Manage budgets for conferences, catering, hospitality, etc
  • Keep detailed records of all contacts and aim to meet or exceed annual sales targets
  • Plan work schedules and timetables, collaborating with the sales team and manager
  • Attend company meetings, technical presentations, and stay updated with clinical data
  • Monitor competitor activity and products, stay informed about NHS developments, and adapt strategies accordingly
  • Develop strategies to increase opportunities for sales growth.

Education

Bachelor of Science with Chemistry -

Skills

  • Quality Management Systems (QMS)
  • Regulatory Compliance
  • Good Manufacturing Practices (GMP)
  • SOP Development and Implementation
  • Risk Assessment and Management
  • Auditing and Inspection
  • Process Improvement
  • Root Cause Analysis
  • Document Control
  • Training and Development
  • Change Control
  • Validation and Qualification
  • Corrective and Preventive Actions (CAPA)
  • Batch Release
  • Quality Metrics and Reporting
  • Leadership and Team Management
  • Problem-solving aptitude
  • Process Validation
  • Materials Inspection

Certification

First Aid

Timeline

QUALITY ASSOCIATE - RELEASER

Slade Health Ltd
09.2023 - Current

QUALITY TEAM LEADER

iMIX Ltd
02.2023 - 09.2023

QUALITY REPRESENTATIVE

Imix Ltd.
12.2021 - 02.2023

CHEMISTRY TECHNICIAN

GMP Pharmaceuticals Ltd
09.2019 - 12.2021

QA OFFICER

GMP Pharmaceuticals Ltd
07.2018 - 08.2019

MEDICAL REPERESEANTATIVE

CACHET PHARMACEUTICALS PVT LTD
08.2012 - 10.2015

Bachelor of Science with Chemistry -

Parth Usdadiya