Anuja Sharma
Qev - Senior Quality Assurance Specialist Document Control Specialist Iii @Lonza
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WORK HISTORY
Qev - Senior Quality Assurance Specialist Document Control Specialist Iii @Lonza
CA, US
Validation and Quality Oversight expert with extensive experience in GMP-regulated biomanufacturing environments. Proven track record of leading system qualification lifecycles, remediating legacy documentation, and driving cross-functional alignment across Facilities, Engineering, Process Automation, and Quality Control. Adept at translating complex technical requirements into traceable, compliant documentation. • System & Process Qualification (Equipment, Facilities, Utilities, CSV, Cleaning, Sterilization, Shipping)• GMP Compliance & Inspection Readiness• Validation Protocol Authoring & Execution• CAPA Leadership & Gap Remediation• Change Control (Assessor & Owner) & Technical Documentation Strategy (URS, FS, DS, CA)• RCA Facilitation & Deviation Management• Cross-Functional Collaboration with SMEs, Engineers, and QA• Veeva QMS, SAP, Master Data Management• Calibration Verification & Instrument Parameter Remediation• SOP Review & Approval & Quality Systems Ownership (QA Auditor, DMS Author). Directed qualification and validation lifecycle activities for manufacturing systems, utilities, and processes in alignment with cGMP and Lonza standards.• Reviewed and approved validation protocols, qualification reports, and GMP-relevant documentation. Assessed impact of discrepancies on qualified states and maintained inspection readiness across all systems.• Partnered with Validation and Engineering teams to design, build, and test systems for reliable performance.• Facilitated RCA sessions to identify root causes of deviations and implemented corrective actions. Served as change assessor and owner in local change management processes. Led remediation of legacy documentation across departments, converting URS, FS, DS, and CA formats to meet current validation standards. Collaborated with Instrument Services and Master Data Management to verify calibration and resolve parameter inconsistencies. Conducted comprehensive proofreading of technical documentation.
EDUCATION
The CRA Training Institute
Clinical Trials
California State University - East Bay
Biology
Ohlone College
Certificate program, Biotechnology
R.C.C.V Girls College
BS, Biology
SKILLS
ABOUT ANUJA SHARMA
Seventeen (17) years extensive experience in Pharmaceutical and Medical Device industries.• Detailed expertise in cGMP and CGLP focusing on Clinical and Commercial production of finished drug products and devices.• Proficiency with LIMS and Statistical Software (JMP) for data.• Competent user of Livelink and SAS, in addition to DCAS (Data capture analysis system) and JMP (Statistical software).• Excellent problem solver; team and discussion facilitator; and analytical representative.
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