Assistant Editor Applicant - Peer Review Management

AKASH VASANT GHAWAT

Life Sciences Professional Quality & Documentation Specialist Aspiring Assistant Editor Pune, Maharashtra +91-985******* ********@*****.*** PROFESSIONAL SUMMARY

Detail-oriented Life Sciences professional (M.Sc. Microbiology) with nearly 7 years of experience in the Biotech and Pharmaceutical industry, specialising in quality assessment, documentation, and compliance within regulated GxP environments. Skilled in reviewing scientific and technical content against defined standards, managing multi-stage workflows from initiation to final decision, and maintaining clear written and verbal communication with cross-functional stakeholders including scientists, auditors, and external partners. Strong subject matter expertise across Microbiology, Life Sciences, and applied laboratory research, combined with proven analytical and logical reasoning, organisational discipline, and decision-making ability developed through Quality Risk Management (ICH Q9), deviation/CAPA investigation, and validation studies. Experienced with structured data systems (LIMS, EDMS, QAMS).

PROFESSIONAL EXPERIENCE

Executive – QC Microbiology — Enzene Biosciences, Pune Oct 2024 – Present

• Manage end-to-end QMS documentation workflow — Deviations, Change Control, CAPA, LIR, and audit records — ensuring each item meets requirements before proceeding to the next stage, similar to a suitability/quality-check gate.

• Conduct Equipment Qualification (URS, Risk Assessment, VP, DQ/IQ/OQ/PQ, FAT, SAT, CSV, Traceability Matrix), requiring careful review, cross-checking, and sign-off against defined criteria.

• Author SOPs, EOPs, study protocols, technical reports, and Quality Risk Management documents in clear, compliant scientific English.

• Perform independent document review to verify accuracy, completeness, and adherence to internal and regulatory standards.

• Coordinate microbial identification and in-house isolate management activities, liaising with multiple internal teams to keep records current.

• Execute protocol-based validation studies (Bioburden, Sterility, BET), tracking each study from planning through to final outcome.

• Apply strong analytical and logical reasoning to evaluate deviation investigations and validation data, ensuring accurate, well-supported conclusions.

• Maintain clear, professional cross-functional communication and business correspondence with QA, regulatory, and external partner teams.

• Manage multiple parallel QMS and validation activities with strong organisational, decision-making, and time-management discipline.

• Mentor and support new team members on QMS documentation, validation procedures, and compliance requirements. Officer – QC Microbiology — Lupin Biotech, Pune Nov 2021 – Oct 2024

• Handled QAMS activities (LIR, Deviations, CAPA, investigation reports, trend analysis), assessing root causes and recommending final resolutions — comparable to reviewing recommendations and communicating final decisions to stakeholders.

• Performed system classification and Computer System Validation (CSV) for LIMS modules in line with ALCOA+ data- integrity principles.

• Authored SOPs, EOPs, protocols, technical reports, and risk-management documentation for internal and audit use.

• Supported LIMS implementation for media, culture, and identification modules, contributing to smoother digital workflows.

• Managed culture-related laboratory activities requiring precision, organisation, and consistent time management across parallel tasks.

Senior Executive – QC Microbiology — Cipla Ltd, Unit-8, Goa Jun 2019 – Nov 2021

• Performed and validated Microbial Limit Testing (MLT) methods for raw materials and finished products, ensuring results met defined acceptance criteria.

• Conducted Bacterial Endotoxin Testing (BET), lysate sensitivity testing, and bioburden analysis with rigorous documentation standards.

• Carried out environmental monitoring across cleanroom grades and supported qualification studies for temperature and humidity distribution.

• Used validated digital systems (LIMS, ICDAS) for structured documentation and data management, comparable to manuscript/editorial tracking systems.

TECHNICAL SKILLS

• Systems & Software: LIMS, EDMS, QAMS, SAP, ICDAS, DMS, Master Control, Advance AQM, SABA, Caliber E-Log

• Life Sciences / Microbiology: Bacterial Endotoxin Testing, Sterility Testing, Microbial Limit Testing, Bioburden Analysis, Environmental Monitoring, Isolate Identification (Vitek 2 Compact, Vitek MS Prime)

• Technical & Scientific Writing (SOPs, Protocols, Investigation & Study Reports)

• Core Business Skills: Email & Business Correspondence, Report Writing, Quality Risk Management (ICH Q9), Audit Documentation, Cross-Team Collaboration

EDUCATION

• M.Sc. Microbiology (Life Sciences) — Y. C. College, Karad, Shivaji University (2019) — 73.42%

• B.Sc. Microbiology (Life Sciences) — Y. C. College, Karad, Shivaji University (2017) — 74.20%

• H.S.C. — Y. C. College, Karad (2014) — 57.54%

• S.S.C. — Bhikoba Patil High School, Chikhali (2012) — 80.73%

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