AKHIL JOSE
Kottarakara
Summary
- Biotechnology graduate and Quality Control Professional with 5+ years of experience in CGMP-regulated biopharma environments. Specialized in BIOVIA Method Development, CSV for analytical systems, and end-to-end Instrument/Equipment Qualification. Proven expertise in LIMS (BIOVIA OneLab, CISPro), QMS, and global compliance standards (GxP, 21 CFR Part 11, FDA, EMEA, TGA). Skilled in managing CAPA, Change Controls, Deviation, OOS, and OOT investigations using TrackWise; streamlined qualification workflows and execution in ValGenesis; and electronic document management and training management in EDMS/ELMS. Known for driving digital transformation, audit readiness, and cross-functional collaboration. Seeking a challenging leadership role to drive continuous improvement, shape quality strategy, mentor teams, and contribute to global health outcomes through innovative, compliant, and future-ready systems.
Overview
1
1
Certification
5
5
years of professional experience
Work History
Senior Executive
OneSource Specialty Pharma Limited
Bangalore
05.2021 - Current
- Led the development, implementation, and validation of the BIOVIA ONE Lab application and product methods to fully digitalize laboratory procedures, enhancing operational efficiency and regulatory compliance.
- Coordinated and led audit preparations for multiple regulatory inspections, including US FDA, EMEA, Taiwan FDA, Saudi FDA, ZaZiBoNa, ANVISA, CDSCO, and other international/ local health authorities to ensure successful outcomes.
- Implemented and validated the BIOVIA CISPro application for streamlined chemical inventory and SDS management, supporting safe handling and traceability.
- Prepared and executed qualification and validation protocols aligned with 21 CFR Part 11, GLP, and GAMP5 standards, leading lifecycle of validation documentation including URS, IRA, FRS, FRA, PVP, CLIA, SLIA, and Traceability Matrix.
- Initiated and investigated QMS elements such as Change Control, CAPA, OOS, OOT, and Deviations using TrackWise, ensuring robust GLP practices and continuous quality improvement.
- Facilitated cross-functional communication and collaboration, improving interdepartmental efficiency and alignment across quality and operational teams.
- Authored and maintained quality system documentation, including instrument qualification records and SOPs, within the EDMS platform, in accordance with Organizational requirements.
- Various Analytical Instruments/ Equipment/ Application Qualifications and (CSV) Computer System Validation in the Quality Control Department, through both manual and ValGenesis applications.
- Coordinated departmental training and documentation workflows as Quality Control training coordinator, overseeing ELMS and EDMS systems.
- Performed analysis of water samples, in-process materials, finished products, and stability samples in accordance with STP procedures, ensuring data integrity and regulatory compliance.
- Formerly Stelis Biopharma Limited, located in Bangalore, Karnataka, India.
Education
Bachelor of Technology - Biotechnology
Dr. M.C Saxena College of Engineering and Technology
Lucknow, U.P., IndiaIntermediate - Science
St. Mary's senior secondary school
Port Blair, Andaman & Nicobar IslandsSkills
- LIMS implementation (Dassault Systems Biovia OneLab)
- QMS Software (TrackWise)
- CAPA
- Deviation/Change control
- OOS
- OOT
- Regulatory Compliance
- Document Control
- Risk Assessment
- Computer System Validations (CSV)
- Instrument/Equipment Qualifications
- Qualification Software: E-ValGenesis
- Chromeleon Software
- Empower Software
- Document Management Solutions
- L&D Software: ELMS
- Authoring & Management of Quality System Documents
- Cross-functional Collaboration
- Training Coordination
Certification
- Pharma Production Course, 08/01/20, Govt. of India
- Workshop on Real time RT-PCR & HPLC, 08/01/20
- CSV & CSA Certification Course, 06/01/25, Pharma Connections (A product of Eduteq Connections Pvt Ltd.)
- Waters Empower Administrative Training, 10/01/25, Waters India Ltd.
Languages
- English
- Hindi
- Malayalam
- Tamil
- Kanada
Personal Information
Nationality: Indian
Hobbies and Interests
- Travelling
- Bike Riding
- Listening Music
- Cooking
- Reading Informative Online Article Contents
- Working Out
- Continuous quality improvement
Languages
Malayalam
First Language
English
Proficient
C2
Hindi
Proficient
C2
Tamil
Upper Intermediate
B2
Timeline
Senior Executive
OneSource Specialty Pharma Limited
05.2021 - Current
Bachelor of Technology - Biotechnology
Dr. M.C Saxena College of Engineering and Technology
Intermediate - Science
St. Mary's senior secondary school