Prerna Mistry
Mississauga,ON
Summary
Experienced Quality Assurance Specialist with 6+ years in the Pharmaceutical and Life Sciences industry specialized in Auditing, Compliance and Training. Consistently delivers thorough and high-quality work across multiple projects. Facilitates effective collaboration with cross-functional teams through exceptional communication skills. Streamlines processes and enhances efficiency with strong organizational abilities. Keen eye for detail and excellent time management talents ensure consistent meeting of deadlines and exceeding of expectations.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist II - Compliance
CooperSurgical
2022.11 - Current
- Implemented Targeted Goals resulting in a 95% Compliance Rate for the Team, aligning with Policies and SOPs.
- Facilitated all stages of Internal and External audit quality system program from planning to execution as a part of the Global Compliance Team.
- Participated in development of Audit Module in Master Control (EDMS). Provided necessary overall and in-depth training to all personnel across all Business units.
- Evaluated processes for areas of improvement and recommended continuous quality enhancement strategies.
- Successfully participated in external audits by AABB, FACT, FDA and Health Canada as the representative of the company.
- Initiated and collaborated on Corrective and Preventative Actions (CAPAs) to provide thorough investigation and risks associated with observations.
- Managed the audit process; identified and reported potential critical observations to senior management.
- Conducted analysis of data to assess risk levels accurately.
- Ensured effective preparation, issuance, and communication of final audit reports to stakeholders and participated in Conflict resolutions or escalations for observations, as needed.
- Engaged in an Inspection readiness program, providing necessary training to staff members when required.
- Maintained regular communication with team leadership regarding quality metrics and provided monthly KPIs and trend of observations for different business units.
Quality and Regulatory Affairs Specialist II
Insception Lifebank By Cooper Surgical
2022.01 - 2022.05
- Ensured adherence to regulations and accreditations by implementing a comprehensive documentation and training regime.
- Streamlined processes by providing comprehensive training on the utilization of Paradigm (EDMS) for implementing Policies, SOPs, Work Instructions and Forms.
- Conducted Gap analysis to assess risk mitigation and process impact of Regulations and Standards.
- Identified trends and collaborated with stakeholders to support site Quality Management.
- Managed the timely preparation and submission of licenses to regulatory bodies such as FDA, Health Canada, and state licensure agencies in multiple locations
- Played a pivotal role in upholding the accreditation certificates with AABB and FACT for HPC/Ts by participating in External Audits and conducting Internal Audits, effectively identifying process deficiencies
- Played a key role in streamlining processes and ensuring consistency across various departments following an acquisition.
- Performed thorough Vendor Audits leading to the implementation of an effective Vendor Management system.
- Provided trend reports on monitored metrics for management's awareness of gaps.
- Implemented Targeted Goals resulting in a 95% Compliance Rate for the Team, aligning with Policies and SOPs.
Quality Assurance Associate
Insception Lifebank
2021.04 - 2022.01
- Developed, reviewed and implemented Policies, SOPs, and forms in Paradigm (EDMS) to enhance Quality Management Systems.
- Initiated Deviations, Non-conformances, Risk Analysis, and CAPAs in collaboration with stakeholders to drive continuous process improvements with a closure rate of 95%.
- Facilitated training on EDMS Document Management and Vendor Management Systems, equipping employees with the necessary skills for efficient system utilization.
- Enhanced operational efficiency with the implementation of a robust Vendor Management system: assigning risk levels and conducting vendor audits.
- Delivered insights on KPI performance through analysis in monthly and quarterly meetings with Key Stakeholders.
Quality Assurance Associate
The Supreme Cannabis
2020.10 - 2020.10
- Supported QAP by assisting with receiving and weighing of dried cannabis.
- Audited packaging processes to identify deviations and maintain compliance
- Conducted comprehensive training sessions, promoting strict adherence to SOP guidelines.
- Streamlined process of supplying Batch Manufacturing Records for commencement of each batch
- Thoroughly inspected changeovers to confirm adherence to quality standards set by regulations.
Pharmacy Data Specialist
MediSystem Pharmacy
2018.01 - 2019.04
- Maintained files, records, and chronologies of entry activities.
- Managed sensitive information responsibly, adhering to strict security protocols and maintaining confidentiality at all times.
- Consistently met deadlines and delivered high-quality work, demonstrating strong commitment to excellence in data management.
- Met prescription fulfillment goals consistently.
Quality Assurance Associate
IPCA Laboratories
2015.07 - 2017.06
- Managed the writing, reviewing, authorization of Change Controls, Deviations, Complaints with subsequent investigations. Additionally responsible for conducting Process Validations and ensuring Batch Release activities while overseeing Recalls, Investigations alongside CAPA effectiveness checks.
- Maintained and updated Standard Operating Procedures (SOPs) by consistently providing support and conducting regular reviews.
- Provided guidance to staff on quality assurance compliance issues
- Ensured efficient management of external suppliers by overseeing auditing processes and approving incoming raw materials as well as quality agreements with relevant stakeholders.
- Performed In Process Quality checks to ensure parameters meeting Acceptable Quality Limit (AQL), while also conducting line clearance before initiating new product
- Implemented stability studies, prepared protocols, executed and drafted reports along with Quality Assurance Manager.
Quality Control Associate (R&D Department)
IPCA Laboratories
2014.10 - 2015.07
- Acquired extensive knowledge of laboratory instruments including Karl-Fisher, USP dissolution apparatus, UV-Vis spectrophotometer, FTIR spectrophotometer, GC and HPLC systems
- Assessed stability data for both pre-formulated and pivotal batches, taking lead in creating ICH guideline-compliant method validation protocol.
- Performed thorough quality assurance checks on wide range of items including raw materials, finished products, in-process components, stability samples, cleaning validation documentation, batch production runs, lot production runs, purified water tests, and release of materials conducted within organization.
- Streamlined in-house methods and verification processes
- Identified and acknowledged any out-of-specification or out-of-trend findings, aiding in completion of lab investigations to ensure adherence to GLP standards.
Education
Post Graduate Diploma - Quality Assurance And Quality Control
Academy of Applied Pharmaceutical Sciences (AAPS)
Toronto, ON12.2020
Master of Pharmacy - Pharmaceutical Sciences
Pune University
Pune, India12.2014
Bachelor of Pharmacy -
Mumbai University
Mumbai, India12.2011
Skills
- Risk Management
- Problem-solving skills
- Quality improvements
- Corrective and Preventative Actions (CAPA)
- Process Development
- Internal and External Audits
- Documentation and Reporting
- Quality Systems Implementation
Certification
- Certified Quality Auditor, American Society of Quality
- Good Manufacturing Practices (GMP) - Level I, II and III
- Technical Writing skills
- Auditing Level I and II
- Chemistry Manufacturing and control
- Regulatory Affairs - Level I and II
Languages
English
Native or Bilingual
Timeline
Quality Assurance Specialist II - Compliance
CooperSurgical
2022.11 - Current
Quality and Regulatory Affairs Specialist II
Insception Lifebank By Cooper Surgical
2022.01 - 2022.05
Quality Assurance Associate
Insception Lifebank
2021.04 - 2022.01
Quality Assurance Associate
The Supreme Cannabis
2020.10 - 2020.10
Pharmacy Data Specialist
MediSystem Pharmacy
2018.01 - 2019.04
Quality Assurance Associate
IPCA Laboratories
2015.07 - 2017.06
Quality Control Associate (R&D Department)
IPCA Laboratories
2014.10 - 2015.07
Post Graduate Diploma - Quality Assurance And Quality Control
Academy of Applied Pharmaceutical Sciences (AAPS)
Master of Pharmacy - Pharmaceutical Sciences
Pune University
Bachelor of Pharmacy -
Mumbai University
- Certified Quality Auditor, American Society of Quality
- Good Manufacturing Practices (GMP) - Level I, II and III
- Technical Writing skills
- Auditing Level I and II
- Chemistry Manufacturing and control
- Regulatory Affairs - Level I and II
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