ABHILASH NAIR
North York,Canada
Summary
Pharmaceutical Industry professional with overall 10+ years of experience in CQV/Serialization/Track and Trace /Machine vision / Production and Validation Engineering who has worked in Project Department, Technical Operations and Project Management. Had extensive exposure in Validations and Engineering, Equipment and Quality Control and the management of pharmaceutical digitalization and manufacturing projects. Well-verse in cGMP and regulatory agencies including USFDA, MHRA, EC, WHO and FDA Functioned as Project manager for the implementation for electronic QMS solutions, E-BMR, online in process checking.
Overview
16
16
years of professional experience
Work History
Quality Engineering Specialist
Alten Working for Baxter Alliston
03.2024 - 06.2024
- Supporting Plant for review and execution of qualification of PPB pour Bottle line, T vision Line.
- Provide Quality Engineering support on projects to implement new product introduction or alternate repair activities.
- Train Technicians, Supervisors and other employees on the use of new products or processes.
- Perform packaging and equipment validations and other verifications/validations to support new product or new repair introductions.
- Provide technical guidance to the Change Control Board; educate members on technical issues associated with assigned projects.
- Followed all company policies and procedures to deliver quality work.
Manufacture Technologist & QA Specialist
Spectral Medical Inc.
05.2023 - 03.2024
- Analyze Production and Complaint data and identify any significant trends.
- Support the Quality Management System (QMS) by performing periodic product, process, and internal audits.
- Support and participate in external audits as needed.
- Work with Operations to resolve material issues.
- Work directly with the OEM to resolve Quality problems identified through complaint investigations and/or other sources of Quality data.
- Perform all other related duties as assigned
Assistant Manager – (CQV)
Micro labs Limited
01.2010 - 12.2022
- Performing of CSV validation in line with the GAMP5, 21 CFR Part 11, EU- Annex 11 requirements.
- Preparation & Execution of Protocols/reports of Validation Plan, URS, DS/FS, GxP Assessment with ER/ES applicability, GAMP Categorization, URS,FRS, IQ, OQ & PQ, and Traceability Matrix, Validation summary report for the processing and packing computerized systems/equipment’s of Manufacturing area.
- Prepared system specific SOPs and modified other affected SOPs for the implementation(IT and Production)
- Supervised day-to-day operations to meet performance, quality and service expectations.
- Maintained a clean, safe, and organized store environment to enhance the customer experience.
- Determined validation approaches, identifies deliverables needed or impacted by a project / enhancement / change for GxP computerized systems
- Supported system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready
- Supported system audit/inspection preparation and execution as CSV subject matter expert
- Provided training and validation/quality knowledge/experience exchange support
Service Engineering (CQV)
ACG Inspection Systems Pvt. Ltd
02.2008 - 10.2009
- Preparing and Execution of protocol/ report of validation plan, URS, DS/FX, GXP ASSECEMENT with ER /ES applicability for production equipment like Bead dispensing system
- Herather180 L GP Gravity Oven, Dickson one display logger.
Education
Diploma in Electronics and Communication Engineering -
State Board of Technical Education
Skills
- Qualification and Validation
- GxP Assessment and GMP Practices
- GMP and QA Compliance
- Multi-tasking and Time Management
- Software Skills
- Verbal and Written Communication
- Microsoft Office, Word, Excel, Power point
- Evaluation of Engineering Systems
- Regulatory Guidelines and Compliance
- Process & Project Management
- Documentation and Reporting
Accomplishments
- Attended MHRA (Medical Health Regulatory Agency), WHO (World Health Organization) and achieved the compliance certificate for the company.
- Efficiently managed the pharmaceutical manufacturing plant operations during the COVID pandemic without any business impact.
Languages
English
Full Professional
Timeline
Quality Engineering Specialist
Alten Working for Baxter Alliston
03.2024 - 06.2024
Manufacture Technologist & QA Specialist
Spectral Medical Inc.
05.2023 - 03.2024
Assistant Manager – (CQV)
Micro labs Limited
01.2010 - 12.2022
Service Engineering (CQV)
ACG Inspection Systems Pvt. Ltd
02.2008 - 10.2009
Diploma in Electronics and Communication Engineering -
State Board of Technical Education
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