Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Ashish Parihar

Sydney

Summary

Results-driven Quality Assurance and Manufacturing Professional with extensive expertise in GMP, cGMP, QMS, and compliance within the pharmaceutical and food manufacturing sectors. Proficient in validation, audits, regulatory oversight, risk management, and leading continuous improvement initiatives. Demonstrated success in navigating FDA, TGA, APVMA, PIC/S, ICH, and ISO standards while managing quality systems and conducting audits to ensure compliance excellence. Renowned for exceptional problem-solving skills, meticulous attention to detail, and a steadfast commitment to maintaining consistent product quality.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Manufacturing Quality Associate

Parnell Manufacturing Pty Ltd
05.2023 - Current
  • Oversaw testing and compliance in production, QC, and packaging, ensuring alignment with FDA, APVMA, USFDA, TGA, and ISO standards.
  • Managed the Quality Management System (QMS), audits, and regulatory inspections with flawless compliance.
  • Developed and implemented cGMP-compliant procedures, including line clearances, AQL inspections, and controlled label management.
  • Monitored training programs for production staff, ensuring compliance with company and regulatory requirements.
  • Conducted OOS/OOT investigations, deviations, and recommended corrective/preventive actions (CAPA).
  • Led QA activities for raw materials and excipient, ensuring identity, purity, and compliance.
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
  • Supported NPI projects, including CCIT and novel ingredient testing.
  • Conducted environmental monitoring and microbiological sampling in line with GMP standards.
  • Streamlined quality metrics monitoring, reducing defect rates and improving process efficiency.
  • Active member of the Continuous Improvement Committee (CIC) and the Workplace Safety Committee, driving initiatives that improved compliance, safety culture, and efficiency.
  • Appointed Fire Warden and First Aid Officer of the manufacturing facility, responsible for emergency preparedness, fire safety drills, first aid response, and staff evacuation training.
  • Provided support in chemical spill management and lab safety, ensuring staff are trained and procedures are followed.

Key Achievements:

  • Successfully maintained comprehensive cGMP compliance across the facility.
  • Played an instrumental role in qualifying new testing equipment, improving QC reliability.
  • Led continuous improvement projects that reduced waste and enhanced productivity.
  • Trained visual inspectors and managed the visual inspection library.

Quality Assurance Officer

Saldoc Fine Food
06.2022 - 12.2022

To ensure SalDoce Fine Foods meets the appropriate quality assurance standards to

produce its products and its customers’ requirements.

To develop new and re-engineer existing products under the SalDoce brands.

SalDoce Quality Assurance Manual - HACCP

- Review and working towards improvement of current SOP's

- Ongoing implementation of HACCP program

- Develop HACCP version covering

• Production

• Customer Complaints

• Supplier Register

• Testing (baking /cooking of products)

Product Development / Specifications

- Detail product specifications for all products manufactured

- Creating specifications for all new products developed

- Managing product development projects

• Testing

Production / Co-Packers

- Ensure co-packers are producing products to required quality standards

• Approving retention samples packaging

• Approving and testing retention samples

• Audit of co packers

- Managing production forms from co-packers

• Resolved issues efficiently and

Operator

Lipa Pharmaceuticals
12.2021 - 05.2022

Inspected finished products for quality and adherence to specifications

• Prepared batch card of day-to-day production processes

• Maintained organized work area by cleaning and removing hazards

• Carried out day-to-day duties accurately and efficiently

• Followed safety processes and protocols while moving powder and operating heavy

machinery to avoid accidents

• Participated in team-building activities to enhance working relationships

• Proved successful working within tight deadlines and fast-paced atmosphere

• Operated various tablet compression and capsule filling machine (ZP15 automatic

rotary pill tablet press machine, ZP 55 automatic rotary tablet press) and Capsule

machine (NJP-3800C Capsule filling machine).

Research Assistant Intern

Homart Pharmaceuticals
02.2021 - 07.2021

Gathered, arranged and corrected research data to create representative graphs and

charts highlighting results for presentations

• Validated incoming data to check information accuracy and integrity while

independently locating and correcting concerns

• Researched and interpreted large volumes of scientific data and literature

• (Assisting team with review of scientific content for Chinese or other herbal

ingredients, as well as providing evidence through generation of data via research

papers or studies)• Supported research and development efforts to create new products and processes

• Helped team meet regulatory requirements by coordinating documentation and filings

• Supported lab activities by maintaining inventory and chemical stocks and cleaning

lab equipment

• Planned, modified and executed research techniques, procedures and tests

• Maintain and review quarantined products for stability and keep track of results.

Quality Assurance Associate

Cyano Pharma
05.2019 - 01.2020

Generated quality control reports for returned products to identify and communicate

patterns.

• Supported audit preparation through research, analysis and presentation

development.

• Educated employees on specific QA standards and confirmed maintenance of

standards.

• Fixed identified issues to increase productivity and boost workflows.

• Provided regular updates to team leadership on quality metrics by communicating

consistency problems or production deficiencies.

• Assessed quality of finished products with careful inspections.

• Communicated quality issues with Drug ferrous sulphate and folic acid tablets I.P

promptly.

• Maintained neat, tidy work environment in GMP area and Manufacturing facility.

• Maintained batch records for compliance and analysis purposes.

• Performed standard first article inspections and random sampling inspections to verify

adherence to customer standards.

Education

Master of Science - Good Manufacturing Practices (GMP)

University of Technology Sydney
12.2021

Bachelor of Science - Pharmacy

IPS Academy College of Pharmacy
08.2019

Skills

  • GMP / cGMP Compliance & Quality Systems
  • Quality Management System (QMS) Oversight
  • FDA, TGA, APVMA, ISO Regulatory Knowledge
  • Validation, Qualification & Instrument Calibration
  • SOP Development & Training Programs
  • Risk Assessments, OOS/OOT Investigations, CAPA
  • HACCP Implementation & Audit Readiness
  • Product Development & NPI Support
  • Microbiology & Chemistry Testing Environmental Monitoring
  • Cross-functional Collaboration & Continuous Improvement
  • 5S methodology

Certification

  • First Aid Officer (Certified) – Workplace First Aid
  • Fire Warden Training – Emergency preparedness and evacuation leadership
  • Chemical Spill Management Training – Certified in laboratory spill response and safe handling procedures

Languages

Hindi
Native or Bilingual
English
Native or Bilingual

Timeline

Manufacturing Quality Associate

Parnell Manufacturing Pty Ltd
05.2023 - Current

Quality Assurance Officer

Saldoc Fine Food
06.2022 - 12.2022

Operator

Lipa Pharmaceuticals
12.2021 - 05.2022

Research Assistant Intern

Homart Pharmaceuticals
02.2021 - 07.2021

Quality Assurance Associate

Cyano Pharma
05.2019 - 01.2020

Bachelor of Science - Pharmacy

IPS Academy College of Pharmacy

Master of Science - Good Manufacturing Practices (GMP)

University of Technology Sydney
Ashish Parihar