Shreyash Panchal
Jersey City,NJ
Summary
Detail-oriented Quality Control Analyst with expertise in regulatory compliance, analytical assessment, and quality control procedures. Dedicated to enhancing product safety and ensuring adherence to industry standards.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Control Analyst
Mak pharma
Jersey City, New Jersey
06.2025 - Current
- Facilitated development and execution of quality control procedures to enhance product safety.
- Conducted audits of internal systems and processes to assess quality effectiveness.
- Collaborated with production teams to ensure compliance with industry standards.
- Utilized analytical tools for evaluating product quality and identifying discrepancies.
- Performed root cause analysis on non-conforming materials to establish corrective actions.
- Developed training programs for personnel on quality control initiatives.
- Maintained documentation of inspection results and quality assurance activities.
- Monitored production processes to ensure adherence to safety regulations.
Quality Control Analyst
B.sharda
Palanpur, Gujarat
03.2021 - 05.2022
- Conducted raw materials and impurity profiling to align with global pharmacopoeia standards.
- Performed method validation using HPLC and UV spectrometry for bioequivalence studies.
- Monitored clinical trial protocols to ensure compliance with good clinical practice guidelines.
- Led risk assessments for analytical testing, identifying areas for process improvement.
Clinical Assistant
Redson laboratories
Ahmedabad, Gujarat
06.2020 - 11.2020
- Conducted stability studies while evaluating product formulation regulatory compliance.
- Ensured stringent quality control through raw material and in-process inspections.
- Identified non-conformities during finished product release audits and implemented corrective actions.
- Contributed to development of risk-based strategies for clinical research and regulatory submissions.
Education
Drug Regulatory Affairs
Long Island University
New York, NY04-2025
B.pharmacy -
Shree S.K.Patel Collage of Pharmaceutical
India06-2022
Skills
Regulatory affairs expertise: FDA, EMA, ICH compliance
Documentation for submissions: INDs and NDAs
Medical device regulations knowledge: GMP standards
Quality assurance practices: CAPA and deviations
Clinical trial design proficiency: protocol development
Analytical methods validation: HPLC and UV spectrometry
Manufacturing compliance processes: batch record reviews
Certification
ICH guidelines certification
Affiliations
Regulatory Process Optimization: Successfully streamlined regulatory submission processes, reducing approval timelines
and ensuring compliance with evolving regulatory standards.
Innovative Product Development: Designed an all-natural facial scrub formulation with enhanced stability, meeting
regulatory requirements for clean-label cosmetics.
Quality & Compliance Enhancement: Spearheaded initiatives that reduced compliance deviations by 40%, improving
overall regulatory readiness.
Clinical & Analytical Excellence: Led process improvements in analytical method validation, increasing testing efficiency and data accuracy.
and ensuring compliance with evolving regulatory standards.
Innovative Product Development: Designed an all-natural facial scrub formulation with enhanced stability, meeting
regulatory requirements for clean-label cosmetics.
Quality & Compliance Enhancement: Spearheaded initiatives that reduced compliance deviations by 40%, improving
overall regulatory readiness.
Clinical & Analytical Excellence: Led process improvements in analytical method validation, increasing testing efficiency and data accuracy.
Timeline
Quality Control Analyst
Mak pharma
06.2025 - Current
Quality Control Analyst
B.sharda
03.2021 - 05.2022
Clinical Assistant
Redson laboratories
06.2020 - 11.2020
Drug Regulatory Affairs
Long Island University
B.pharmacy -
Shree S.K.Patel Collage of Pharmaceutical