Vanmeeganathan Balakrishnan Email & Phone Number

Toronto, On, Ca

Greater Toronto Area, Canada

San Francisco Bay Area

• Manage the delivery for IT Quality & Compliance services including Computer System Validation, IT infrastructure qualification, SOX • Leads the compliance delivery team and oversee daily activities of delivery team and provide direction and guidance as needed • Developing validation/qualification/migration/verification strategies for software, data, hardware, infrastructure/components and/or business processes prior to release into a live environment per company procedure(s) • Leads the effort to create, manage, and/or maintains validation of the GxP computerized systems. • Leads the effort for value creation activities, conceptualized the continuous compliance solution for paperless continuous monitoring system and managed the implementation of the same • Providing validation/verification/qualification training to stake holders as necessary • Perform Designing of SOX controls, SOX controls testing, evaluation of SOX control deficiencies and remediation plans • Managing relationships with key customers and stake holders to ensure the total validation/verification/qualification solution delivered to the customer meets/exceeds expectations.

Hyderabad Area, India

- Responsible for providing regulatory compliance & validation consulting services to the companies in life sciences industry in the following aspects - Governance and Strategic Service: establishing comprehensive computer system validation policies, guidelines, procedures, templates and forms (e.g Computer system validation policy, guideline, SDLC procedure, Change Management, templates for validation deliverables) - Tactical Service: Validation planning based on GxP applicability, risk, complexity and novelty of the system, validation execution and validation reporting - Operational Services: Managing the specific validation activities and generating validation deliverables as defined in the validation plan.

Hyderabad Area, India

Gurgaon, Haryana, India

• Act as a validation lead for global/site IT validation projects.• Responsible for designing overall computer system validation strategy.• Working closely with Information Technology, Quality Assurance and system owners to effectively and efficiently implement new systems, system upgrades, or system modifications.• Work with IT and User Groups to evaluate change control requests for GxP systems.• Development, implementation, and enforcement of computer validation policies and practices.• Conduct regular compliance internal audits, part 11 compliance assessment, provide guidance & support and ensure closure of audit findings with the help of desired team.• Conduct vendor audits to ensure that the solutions being implemented conform to regulatory standards and internal processes being followed at Ranbaxy.• Provide desired support related to computer system validations during audits & inspection done by regulatory agencies etc.

Bangaon Area, India

• Responsible for providing validation, compliance, and engineering design consulting services for pharmaceutical and biotech companies.• Responsible for Internal QA review and approval of validation deliverables.• Design and develop computer system validation deliverables for Lab software systems, Automated Process Control Systems (DCS/ SCADA), IT Infrastructure, SAP R/3 validations.• Develop Risk Management strategies, perform GAP analysis and apply Risk Management for validation and Part 11 compliance.

Cuddalore, Tamil Nadu, India

• Working closely with the Research & Development, Scale up and Regulatory affairs to commercialize products from R & D to Manufacturing.• Preparing Basic Engineering Document (Equipment technical data sheet, Mass & Energy Balance, Process & Equipment flow diagrams) based on Pilot plant data for commercialization of drug API/Intermediate.• Working in the area of process optimization, trouble shooting, cost reduction, efficiency improvement.• Guiding for the preparation of GMP engineering drawings and take part in the review.• Preparing protocol for Equipments/Systems qualification and take part in the review of the qualification documents (DQ/IQ/OQ/PQ) for equipments/Systems against user requirements and functional specifications.• Investigating on existing causes of Non-conformity /Problem pertaining to System/Process.