PARTH VIJAY SHAH
Norwood,MA
Summary
Experienced Pharmaceutical and Biotech quality assurance professional with 4+ years of expertise in GDP and GMP compliance. Proficient in BPR review, Batch disposition, Floor support, Quality system compliance, SOP revision, Document life cycle, EDMS, LMS, File room management, Archival filing, and audit compliance. Recognized for strategic approach to business operations, resulting in high productivity and efficiency. Specialized in process optimization, project management, and data analysis for streamlined workflows and enhanced operational efficacy. Strong communication, problem-solving, and leadership skills drive team success and achieve organizational goals.
Overview
6
6
years of professional experience
Work History
Sr. Specialist, Quality Assurance
Moderna Therapeutics, Inc
02.2022 - Current
- Spearhead initiatives to maintain alignment with cGMP (current Good Manufacturing Practices) and regulatory standards, ensuring consistent adherence to FDA, EMA, and ICH guidelines across operations
- Authored and developed batch records, standard operating procedures (SOPs), risk assessments, and training materials to support the successful startup of the Norwood facility
- Conducted reviews and provided quality contact approvals for manufacturing deviations, CAPA’s, change controls, and part number creation and setup
- Collaborated and performed closely with cross-functional teams to ensure timely and compliant disposition of plasmids, drug substances, and drug products
- Demonstrated comprehensive knowledge of manufacturing compliance, quality disposition processes, and quality system reviews to maintain operational excellence
- Enforced adherence to cGMPs, standard operating procedures, and manufacturing documentation standards by establishing clear written procedures and ensuring accurate documentation of equipment operations, process instructions, and process data
- Developed and managed comprehensive documentation for audits, inspections, and process validation activities, ensuring data integrity, accuracy, and transparency
- Led facility walkthroughs and cross-functional collaborations to proactively identify and resolve operational challenges, including airlock workflows, gowning protocols, and room classification clarifications
QA Operation Specialist
Cognate Bio-Services (ITC Management Group)
12.2020 - 02.2022
- Conducted comprehensive batch record reviews for small molecules and biologics, including drug substances, drug products, and packaging/labeling, to ensure full compliance with cGMPs and regulatory requirements
- Facilitated the disposition of clinical and commercial products by fostering effective partnerships with contract manufacturers and testing laboratories to resolve quality issues promptly
- Oversaw the issuance, retrieval, and review of floor documentation, including SOPs, batch documentation, deviations, complaints, and other quality-related issues
- Supported the management and closure of quality systems such as deviations, change controls, CAPAs, supplier change notices, and non-compliance reports
- Ensured adherence to cGMPs and corporate SOPs through activities including batch record reviews, investigation of temperature excursions, document archival, and complaint resolution within project and regulatory timelines
- Provided on-the-job training and daily guidance to junior personnel in EDMS (Electronic Document Management System) activities to promote team development and operational efficiency
- Authored and revised standard operating procedures (SOPs) and work instructions to drive continuous improvement in manufacturing processes and quality systems
Quality Assurance Specialist
Bittu Pharmaceuticals
01.2019 - 12.2019
- Conducted equipment inspections, periodic line checks, and verification of raw materials against quality standards, while executing packaging, quality, and labeling checks to ensure compliance
- Reviewed and approved raw material analyses, in-process quality control (IPQC), and finished product quality control (FPQC) checklists
- Ensured compliance with GMP guidelines and ISO standards in manufacturing plant operations
- Performed batch review checklists and verified specifications for Certificates of Analysis (COA) and Certificates of Conformance (COC)
- Assisted in the preparation and review of SOPs, batch documentation, technical reports, and protocols
- Executed corrective actions for quality incidents and implemented CAPA resolutions
- Supported QP release, regulatory filings, audits, QA compliance initiatives, and overall product quality assurance efforts
Education
Master of Science - Regulatory Affairs in drugs, biologics and medical devices
Northeastern University
Boston, MABachelor of Pharmacy -
NMIMS University
IndiaSkills
- GDP
- GMP
- Floor QA
- QA Batch record
- Quality System
- Change control
- Deviation
- CAPA
- Investigation support
- Batch disposition
- DS
- DP
- FDP
- Technical writing
- QA Documentation
- Archiving
- Retrieval
- EDMS workflow
- Document Life cycle
- Audit compliance
- EDMS
- Veeva
- MS Project
- Advanced Excel
- Microsoft Access
- Continuous improvement
- Team collaboration
- Process optimization
- Failure management
- Operational enhancement
- Time management
- Project planning
- Process improvement
- Team leadership
Timeline
Sr. Specialist, Quality Assurance
Moderna Therapeutics, Inc
02.2022 - Current
QA Operation Specialist
Cognate Bio-Services (ITC Management Group)
12.2020 - 02.2022
Quality Assurance Specialist
Bittu Pharmaceuticals
01.2019 - 12.2019
Master of Science - Regulatory Affairs in drugs, biologics and medical devices
Northeastern University
Bachelor of Pharmacy -
NMIMS University
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