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Pathik Patel
Cybersecurity Auditor/ InfoSec/ IAM Analyst
Syracuse, NY, United States
Details
Experience:
Worked for fortune 5000 clientele in various domains such as Healthcare, Banking and Pharmaceuticals.
• Evaluate and maintained compliance of administrative, physical, technical, organizational and polices safeguards to maintain HIPAA compliance base on Office of Civil Right (OCR) protocol, NIST SP 800-66 Rev1 and security controls (NIST SP 800-53).
• Conducted IT controls risk assessments by reviewing organizational policies, SOPs, and guidelines based on the NIST 800-66 & 53 controls.
• Conducted audit within the organization and formulated test plans, documented gaps.
• Coordinates a penetration testing, internal and external vulnerability scan as well as remediation plans.
• Development of HIPAA compliance reports, documenting auditing findings and development of corrective actions plans.
• Develops remediation plans and assign to various owners whilst advising and remediating security identified risk - Control security occurrences and proceedings pertaining to electronic protected health information (ePHI).
• Worked with application managers in scoping, organizing, planning, and conducting application risk assessments.
• Recommend customized phishing programs based on industry best practices and customer goals.
• Review, edit, and create procedural and technical documentation for internal and external use.
• Generating Log reports using Splunk and, also generate data gathered from applications.
• Performed Control Self-Assessment (CSA) for new applications in the development stage that involved, coordinating and walkthroughs.
• Mapped controls internally to industry recognized frameworks such as ISO 27K, NIST Cyber Security Framework, and COBIT.
• Promptly reported security issues, vulnerabilities, and violations to the Information Risk Management team, and obtained additional supporting information to identify a successful plan for remediation.
2019 : Present
GuruSchools LLC
Senior Information Security Analyst/ Cybersecurity Auditor
• Assisted in conducting annual audit of system containing records for internal and external audits.
• Helped the team in security operation including user account creation, assigning level of access and modification as needed
• Manually reviewed logs and provided documentation support as needed
• Participate in drafting test controls.
• Participate in help desk team and served as appoint of contact to resolve technical security issues.
• Participate in creating and implementing LIMS Access Management.
• Provisioned and de-provisioned systems security access to users based on the appropriate requests and in-line with strict process and procedure.
• Assisted in developing security policies, guidelines and procedures for risk management, data classification and security in the Information System Life Cycle (ISLC)
2015 : 2018
West-Ward Pharmaceuticals
Business Analyst / Information Security
• Support site supplier program, perform audit planning, scheduling, execution, documentation, reporting and follow-up to assure compliance to site supplier management program.
• Develop and maintain supplier audit schedule.
• Review audit observation corrective action and assess effectiveness.
• Participate in Corporate / Internal audits, when needed.
• Prepare risk assessment as necessary for suppliers who do not allow audits.
• Report supplier risk, audit status, and follow up on audit commitments.
• Provide cGMP / GXP, technical and auditing training to other QA and Operation personnel through participating in the audit process, management review and cGMP training program ownership.
• Communicate Identified Compliance Risk to management.
• Create and maintain written and signed records of all audits and inspections as required.
• Responsible for revising existing compliance SOPs and Conduct training for team members
• Participate in project planning starting with method development to analytical technology transfer to respective manufacturing site.
2013 : 2015
West-Ward Pharmaceuticals
Sr. Quality Auditor, A R&D
• Responsible and required of expert understanding of analytical methods (UHPLC, HPLC and Dissolution), comparability protocols, stability strategies, impurities profiles, degradation products, tech transfer, process validation and Chemistry, Manufacturing and Control (CMC) contents of regulatory submission, ICH guideline, and emerging FDA requirements in the analytical field.
• Successfully developed, validate and transfer analytical chromatographic and stability indicating method for topical anesthetic gel, cough and cold syrup, HARTZ hot spot.
• Successfully developed and validate analytical HPLC-RI method for tolerance beverage by creating a sample matrix.
• Expertise in stability as well as Finished product testing for Tablets, Gels, Liquids, Soft gel Capsules on HPLC, UV, Dissolution.
• Responsible to manage a team of Chemists as a group leader for routine finished product/Stability sample analysis and ongoing project.
• Responsible for introducing new instrumentation, setup, qualification and implementation in laboratory.
• Responsible to audit analytical data, technical IQ/OQ/PQ protocols.
• Responsible for writing of operating and calibration sops for new instrumentation, as well as troubleshoot the damaged instrument and calibrating the existing HPLC, UHPLC Instruments and maintain them up and running.
• Supporting Associate director for resolving investigation by implementing of CAPA as well as involve in resolving customer complain.
• Responsible for revised and update Standard Operating Procedure for Quality Control unit as per cGMP requirement and USP guideline.
• Responsible for providing training, guideline and supporting feedback to other scientist working within same group as well as in Quality Control Lab.
2010 : 2013
Medical Product laboratory
Sr. Business Analyst II, Research & Development
• Responsible and required of expert understanding of analytical methods (HPLC and Dissolution), comparability protocols, stability strategies, impurities profiles, degradation products, tech transfer, process validation and Chemistry, Manufacturing and Control (CMC) contents of regulatory submission, ICH guideline, and emerging FDA requirements in the analytical field.
• Responsible to manage a team of Chemists as a group leader for routine Finished product/Stability sample analysis and ongoing project.
• Successfully developed and validate analytical chromatographic assay, dissolution and stability indicating method for prescription drug used in Gout treatment.
• Successfully developed and validate analytical chromatographic assay, dissolution and stability indicating method for drug used as stool softener and also for skin infection.
• Successfully developed and validate analytical chromatographic assay, dissolution and stability indicating method for control drug by DEA use in the treatment of somatic factor in Gastrointestinal disorder
• Expertise in writing of validation protocol as well as validation reports as per current ICH guideline.
• Responsible for revised and update Standard Operating Procedure for Quality Control unit as per cGMP requirement and USP guideline.
• Successfully introduce and set up Particle size analyzer using laser diffraction technology, write operating procedure and train the chemist for routine analysis.
2008 : 2010
Sunrise Pharmaceutical, Inc
Business Analyst, Research & Development
• Evaluate and maintained compliance of administrative, physical, technical, organizational and polices safeguards to maintain HIPAA compliance base on Office of Civil Right (OCR) protocol, NIST SP 800-66 Rev1 and security controls (NIST SP 800-53).
• Conducted IT controls risk assessments by reviewing organizational policies, SOPs, and guidelines based on the NIST 800-66 & 53 controls.
• Conducted audit within the organization and formulated test plans, documented gaps.
• Coordinates a penetration testing, internal and external vulnerability scan as well as remediation plans.
• Development of HIPAA compliance reports, documenting auditing findings and development of corrective actions plans.
• Develops remediation plans and assign to various owners whilst advising and remediating security identified risk - Control security occurrences and proceedings pertaining to electronic protected health information (ePHI).
• Worked with application managers in scoping, organizing, planning, and conducting application risk assessments.
• Recommend customized phishing programs based on industry best practices and customer goals.
• Review, edit, and create procedural and technical documentation for internal and external use.
• Generating Log reports using Splunk and, also generate data gathered from applications.
• Performed Control Self-Assessment (CSA) for new applications in the development stage that involved, coordinating and walkthroughs.
• Mapped controls internally to industry recognized frameworks such as ISO 27K, NIST Cyber Security Framework, and COBIT.
• Promptly reported security issues, vulnerabilities, and violations to the Information Risk Management team, and obtained additional supporting information to identify a successful plan for remediation.
2019 : Present
GuruSchools LLC
Senior Information Security Analyst/ Cybersecurity Auditor
• Assisted in conducting annual audit of system containing records for internal and external audits.
• Helped the team in security operation including user account creation, assigning level of access and modification as needed
• Manually reviewed logs and provided documentation support as needed
• Participate in drafting test controls.
• Participate in help desk team and served as appoint of contact to resolve technical security issues.
• Participate in creating and implementing LIMS Access Management.
• Provisioned and de-provisioned systems security access to users based on the appropriate requests and in-line with strict process and procedure.
• Assisted in developing security policies, guidelines and procedures for risk management, data classification and security in the Information System Life Cycle (ISLC)
2015 : 2018
West-Ward Pharmaceuticals
Business Analyst / Information Security
• Support site supplier program, perform audit planning, scheduling, execution, documentation, reporting and follow-up to assure compliance to site supplier management program.
• Develop and maintain supplier audit schedule.
• Review audit observation corrective action and assess effectiveness.
• Participate in Corporate / Internal audits, when needed.
• Prepare risk assessment as necessary for suppliers who do not allow audits.
• Report supplier risk, audit status, and follow up on audit commitments.
• Provide cGMP / GXP, technical and auditing training to other QA and Operation personnel through participating in the audit process, management review and cGMP training program ownership.
• Communicate Identified Compliance Risk to management.
• Create and maintain written and signed records of all audits and inspections as required.
• Responsible for revising existing compliance SOPs and Conduct training for team members
• Participate in project planning starting with method development to analytical technology transfer to respective manufacturing site.
2013 : 2015
West-Ward Pharmaceuticals
Sr. Quality Auditor, A R&D
• Responsible and required of expert understanding of analytical methods (UHPLC, HPLC and Dissolution), comparability protocols, stability strategies, impurities profiles, degradation products, tech transfer, process validation and Chemistry, Manufacturing and Control (CMC) contents of regulatory submission, ICH guideline, and emerging FDA requirements in the analytical field.
• Successfully developed, validate and transfer analytical chromatographic and stability indicating method for topical anesthetic gel, cough and cold syrup, HARTZ hot spot.
• Successfully developed and validate analytical HPLC-RI method for tolerance beverage by creating a sample matrix.
• Expertise in stability as well as Finished product testing for Tablets, Gels, Liquids, Soft gel Capsules on HPLC, UV, Dissolution.
• Responsible to manage a team of Chemists as a group leader for routine finished product/Stability sample analysis and ongoing project.
• Responsible for introducing new instrumentation, setup, qualification and implementation in laboratory.
• Responsible to audit analytical data, technical IQ/OQ/PQ protocols.
• Responsible for writing of operating and calibration sops for new instrumentation, as well as troubleshoot the damaged instrument and calibrating the existing HPLC, UHPLC Instruments and maintain them up and running.
• Supporting Associate director for resolving investigation by implementing of CAPA as well as involve in resolving customer complain.
• Responsible for revised and update Standard Operating Procedure for Quality Control unit as per cGMP requirement and USP guideline.
• Responsible for providing training, guideline and supporting feedback to other scientist working within same group as well as in Quality Control Lab.
2010 : 2013
Medical Product laboratory
Sr. Business Analyst II, Research & Development
• Responsible and required of expert understanding of analytical methods (HPLC and Dissolution), comparability protocols, stability strategies, impurities profiles, degradation products, tech transfer, process validation and Chemistry, Manufacturing and Control (CMC) contents of regulatory submission, ICH guideline, and emerging FDA requirements in the analytical field.
• Responsible to manage a team of Chemists as a group leader for routine Finished product/Stability sample analysis and ongoing project.
• Successfully developed and validate analytical chromatographic assay, dissolution and stability indicating method for prescription drug used in Gout treatment.
• Successfully developed and validate analytical chromatographic assay, dissolution and stability indicating method for drug used as stool softener and also for skin infection.
• Successfully developed and validate analytical chromatographic assay, dissolution and stability indicating method for control drug by DEA use in the treatment of somatic factor in Gastrointestinal disorder
• Expertise in writing of validation protocol as well as validation reports as per current ICH guideline.
• Responsible for revised and update Standard Operating Procedure for Quality Control unit as per cGMP requirement and USP guideline.
• Successfully introduce and set up Particle size analyzer using laser diffraction technology, write operating procedure and train the chemist for routine analysis.
2008 : 2010
Sunrise Pharmaceutical, Inc
Business Analyst, Research & Development
Company:
GuruSchools LLC
About
Resourceful, process-driven senior professional with plenty of knowledge in Cyber Security Auditor, Identity Access Management, Information Security. Instrumental in constructing and nurturing training programs and initiative to enhance and increase team productivity and performance, while creating key policies and controls to support end-user success. Risk Management Framework (RMF), NIST Special Publications (NIST SP 800-*), NIST Risk Management Framework (RMF). Knowledge about HIPAA guidelines. Working knowledge of ISO standards. Thrive in a fast paced, challenging environment, and enjoy working as an integral member of risk management teams. Self-driven individual who is capable and excited to learn about new technologies.
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