Sibgath Ulla
Quality assurance Manager / Quality Manager
- Role
- Manager at Shah Eye Care
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Sibgath Ulla
Profile Summary Compliance-focused QA/QMS Lead with 24+ years of experience in Quality Control, Quality Assurance, Regulatory Compliance, and Quality Management Systems across pharmaceutical, bioanalytical, nutraceutical, and medical device companies. Proven expertise in managing audits, establishing QMS in alignment with international standards, and ensuring adherence to evolving regulatory requirements. Track record of supporting organizations in delivering safe, effective, and compliant products. Organizations Served: Shah Eye Care, Analytica Chemie, Lotus Labs, Stabicon Life Sciences, Himalaya Drug Company Core Responsibilities Implement, monitor, and improve QMS in compliance with ISO 9001:2015, ISO 17025:2017, ISO 13485:2016, ISO 14001, ISO 45001, and 21 CFR Parts 11 & 820. Lead and host internal/external audits (ISO certifiers, NABL, FDA, CDSCO, customer audits). Supervise document control: SOPs, WIs, quality manuals, validation protocols. Oversee calibration, qualification, and validation of equipment, instruments, and software (DQ, IQ, OQ, PQ, CSV). Handle complaints, technical queries, CAPA, and root cause analysis. Conduct QMS training for stakeholders and onboarding employees on policies, audit readiness, and data integrity. Collaborate cross-functionally for WHO, FDA, MHRA, EU MDR, and ISO compliance. Review and approve data, protocols, SOPs, PMS/PSUR, DMF, PMCF, Technical Files, DHF, DHR, risk management reports. Support risk management, EHS/OSHA compliance, waste control, and process optimization. Qualifications & Skills Education: B.Pharma (Bachelor’s in Pharmacy) Certifications: Lead Auditor – ISO 9001:2015; Internal Auditor – ISO 17025:2017, ISO 13485:2016 In-depth knowledge of GMP, GLP, GCP, ICH, FDA, EU compliance standards. Proficient in LIMS, ERP, PLMS/DMS, Logicmind QMS software. Technical expertise: HPLC, LCMS, GCMS, FTIR, ICPMS, validation frameworks. Strong leadership in audit management, documentation systems improvement, SOP authorship, and team development.
Experience
Manager
Oct 2024 — Present · Davangere Taluka, IN
Education
Bapuji College of Pharmacy
Bachelor's degree
1995 — 2000
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