Siddharth Tailor
Senior Associate, Quality Operations @Resilience
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WORK HISTORY
Senior Associate, Quality Operations @Resilience
Mississauga, ON, CA
Provided on-floor GMP oversight for aseptic manufacturing processes, including microbial culture seeding, sterile filtration, purification, and fill/finish operations within Grade A/B cleanrooms.•Conducted aseptic audits, line clearances, and environmental monitoring support to ensure compliance during sterile filling activities in accordance with regulatory and internal quality standards.•Performed Visual AQL inspections of liquid vial products and supported visual inspection qualification and validation activities.•Executed QA walkthroughs and monthly inspections across manufacturing areas (upstream, downstream, utilities) and QC labs to proactively identify and address compliance gaps.•Reviewed and approved executed batch records (BPRs, buffer/solution forms) and associated documentation, ensuring timely lot disposition based on critical quality attributes and test results.•Managed lifecycle of controlled documents, including issuance, reconciliation, archival, and verification prior to production use, ensuring document control compliance.•Supported deviation investigations and risk assessments for unplanned events, AQL failures, and client-requested analytical testing; authored and reviewed associated protocols.•Performed compliance reviews for change controls (CC/DCC) involving SOP updates, equipment changes, and test method revisions, ensuring adherence to cGMP and quality system requirements.•Collaborated with cross-functional teams during audits and regulatory inspections, contributing to zero critical observations.
EDUCATION
Veer Narmad South Gujarat University, Surat
Bachelor's degree, Biotechnology
Durham College
Post Secondary Diploma, Chemical Technology/Technician
ABOUT SIDDHARTH TAILOR
Senior Quality Assurance professional with 8 years of experience in GMP-regulated environments, supporting manufacturing operations through real-time on-the-floor oversight, batch record review, documentation, and Visual inspection. Proven ability to uphold compliance with regulatory standards (FDA, Health Canada, EMA), support quality system, and contribute to continuous improvement initiatives.Key strengths include: Aseptic manufacturing oversight Deviation and Change Control Batch record review and release Documentation control and quality systems Audit support and inspection readiness
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