Natalia Fernandes_Quality Assurance MAY 15
Published on: Mar 3, 2016
Transcripts - Natalia Fernandes_Quality Assurance MAY 15
Training and Compliance Manager
A total experience 7+ years in TCS with 5+ years in Life Science and Healthcare domain
(Clinical Research).Overall work experience of more than 8 years. I am a Microbiology
graduate from Mumbai University with additional subject as Biotechnology. Advanced
Certificate Course in Clinical Research with ICH GCP certification. Currently working as
the Training and Compliance Manager/Lead Quality Coordinator for clinical domains like
Clinical Data management, Pharmacovigilance, Regulatory, Clinical Operations, eTMF
and Clinical Trial management system processes in the largest Life Science engagement
with TCS. I am a quick learner with good multitasking skills. I am the quality and
audit/inspection compliance coordinator. I am a certified Six Sigma Yellow Belt and Green
Belt. Apart from being into Quality Assurance (KEY ROLE), I also have additional
experiences in the following fields.
1. Relationship Crisis Management Lead (Risk Assessment and Contingency Planning)-Jan
2012 till date
2. Information Security Coordinator- Jan 2012 till date
3. Health Safety & Environment SPOC-2014-2015
4. Human Resource Catalyst-2010-2011
5. Information Security Auditor (all domains in TCS)– 2013-2014
Degree and Date Institute/University Percentage of
Course in Clinical Research
CHM College, Dept of
BSC Microbiology Mar
Mumbai First Class
HSC Mar 2004 Mumbai First Class
SSC Mar 2002 Mumbai Distinction
MAY 2015 1
Address: Aries APT, Room no: A-1,
Behind Bethel Church,
Tata Consultancy Services - Life Sciences and Healthcare Vertical-CLINICAL
Current Designation: Lead Quality Coordinator/Training and Compliance Manager (Key
Domain: Quality Assurance (Audits and Inspections Compliance)
Tenure: JAN 2012 till Date
• Play a key role in ensuring compliance to ICH GCP guidelines for all projects dealing
with regulatory compliance areas for Pharmaceutical Sector.
• Ensure and verify compliance to all applicable SOPs, regulations, rules, SLAs and
statutes with regard to GCP regulation through internal audits.
• Conducting quality reviews, identifying gaps and recommending improvements for the
all the client domains. Conducting mock audits and providing the findings to the
domains before an actual scheduled audit and working with the teams to address
• Assist in Root cause analysis and facilitate robust and sustainable Corrective and
Preventive Actions across applicable projects.
• Face to Face meetings and via calls with the respective domain clients to highlight any
potential issues with regards to Audits/Inspections and provide resolutions.
• Single point of contact for the Client Quality Assurance department
• Creation, review and dissemination of new and revised SOPs/WI/NTFs/Deviations to
the target audience and tracking compliance to training requirement.
• Communicate with the SOP owners on any SOP that may need to change based on RCA
• Conduct periodic checks to ensure processes are robust and are being implemented.
• Acting as a Co-auditor with the ICH GCP compliance Manager for conducting Internal
GCP Compliance Audit.
• Responsible for implementing the Audit and Inspection readiness as per the applicable
• Ensuring that all the CAPAs are implemented & closed in a timely manner
• Develop and deliver key quality or compliance training programs in order to enhance
compliance awareness within the Organization.
• Generate reports for senior management on improvements, gaps/non compliance etc
• Responsible for on boarding and exit client and TCS defined formalities for resources.
• Participate in recruitment and selection of members in the Quality team.
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2. Compliance Trainer JAN 2012 till Date
• Training the new batch of associates on ICH GCP,AE Reporting, BCP and Information
• Train resources on Audit and Inspection readiness.
• Conduct lessons learnt from audits (internal and external) and inspection sessions with
resources and senior management.
• Connect with domains to impart regular updates & reinforce compliance awareness.
3. Risk Management-JAN 2012 till Date
Role: Relationship Crisis Management Lead
• Prepare TCS Customer BCP which is a mutually agreed document. Initiate periodic
review as per defined cycle, updates collated from all internal and client management,
queries addressed and sign off the final document.
• Identifying Mission Critical Application projects in the account based on MSA.
• Carrying out Business Impact Analysis, work out recovery strategies.
• Maintaining a test calendar for forthcoming year for the Account.
• Conducting the monthly BCP drills and ensuring that test drills are carried out as planned
& getting the same approved from BCP committee.
• Maintaining the test logs with date and time and other reports.
• Facilitating and leading the BCP sessions while internal and client audits to present the
BCP process and compliance
• Ensuring periodic awareness / training sessions on BCP.
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• Maintaining up to date contact list of all key associates and critical emergency numbers,
with periodic checks for accuracy
1. Information Security- JAN 2012 till Date
Role: Information Security Coordinator
• Documenting security requirements in consultation with the client and internal IS
• Monitoring deployment of security procedures within the relationship.
• Training all associates in the relationship on customer specific security requirements.
• Promoting security culture in the domain by regular compliance and random checks.
• Tracking security awareness/ training status of the associates in the relationship.
• Monitoring compliance to induction and release process in the relationship.
• Reconciliation of Physical access and Logical access for segregated areas of the
• Coordinating IT Security client audits/ external audits for the relationship and address the
CAPAs based on timelines.
2. Health Safety and Environment SPOC- APR 2014 till Date
• Coordinating all the HSE activities at the organizational level by creating awareness
among people through conducting poster competitions, collating ideas from people to
address domain HSE concerns.
• Suggested and implemented improvement ideas in the domains to attain compliance.
• Monitoring the effectiveness of the HSE in the domains.
• Ensuring compliance to HSE procedures and guideline across the domain
• Providing training to all concerned on achieving compliance to HSE
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• Providing continuous guidance to the Centre HSE Committee to achieve HSE
compliance for the domain.
2 Tata Consultancy Services - Life Sciences and Healthcare Vertical
Designation: Clinical Documentation Specialist (Regulatory)
Tenure: OCT 2009 to DEC 2011
• Handling Trial Master File Documents and registering the same onto customer’s database
• Compliance to customer SOPs, regulatory requirements, guidelines and procedure
• Discrepancy management in accordance with operating procedures manual and as per
• Communicate with client for TMF document discrepancies and technical issues.
• Collaborate with study management personnel (internal or external) and resolve clinical
• Escalates unresolved issues to immediate supervisor and customer support team to follow
up for meeting agreed timelines.
• Provide support during internal and external audits and inspections.
• Act as primary interface to receipt and shipment of records from investigators and long
term archival respectively.
• Understanding requirements from Leadership team and preparing ad-hoc reports for data
analysis and process trending.
• Acting as a mentor for the new hires and ensuring that they gain the knowledge to handle
the processes independently.
• Implemented technical expertise
• Imparting the latest updates and process expertise to all my team mates on regular basis.
3 Tata Consultancy Services – Travel and Tourism/DHL Vertical
MAY 2015 5
Designation: Backup Team Lead and Trainer
Tenure: Mar 2008 – Oct 2009
• Serve as a back-up Team Lead.
• Handling workload management and distribution of shipments to be completed as per
timelines by the team.
• Leading the Client Meetings to discuss TAT and Quality Sheets.
• Manifestation/Indexing the DHL Shipments for Australia, Korea, Japan and New Zealand
• Data Cleansing and Classification as per country custom requirements.
• Training the new associates on manifestation.
• Had travelled to transition Australian manifestation process to team in Pune
4 Convergys services India Pvt. Ltd
Period: - July 2007 – March 2008.
Role: - Customer Care Executive
• Customer Support with regards to one of the biggest Prepaid Services in Australia.
• Connecting with Australian customers to resolve their queries via inbound calling
• Training new hires and provide on floor support.
Basic and Advanced Excel Course
Root Cause Analysis and Structured Problem Solving
Diploma in Software Engineering
MAY 2015 6
1. Received second prize as an HR Catalyst in 2011
2. Received management and client appreciations for effective and timely Client Report
3. Received “Special Initiative” Corporate Award by Corporate ISM Head for being the
Best ISC among all BPS domains-Apr 2014
4. Received “Special Initiative” by Corporate HSE Auditor for improvements implemented
as an HSE SPOC-Feb 2015
5. Six Sigma Yellow Belt Certified
6. Green Belt Certified in 2014
Marital status: Married.
Date of birth: 13th October 1986.
Languages known: English, Hindi, Marathi and Konkani
Hobbies: Dancing, Music and learning new recipes.
Strengths: Hardworking, Fast Learner, Confident, Ambitious &
Objective in Life: To improve, learn & grow constantly.
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