1. SANKET KUMAR PATRA
Mobile: +91-9004643540 / +91-9930228112
Email: sanket.patro@gmail.com
OBJECTIVE
Seeking opportunity in any progressive organization that provides opportunity to utilize my skills and
knowledge for the benefit of the company & which provide scope for my career improvement in Quality
Management Systems.
PROFILE SUMMARY
 A competent professional with around 10 years of rich experience in Quality Assurance and Business
Development.
 Demonstrated excellence in investigations for Customer Complaints, Deviations and Quality Events, CAPA
management, Audit support during various Health Authority inspections and response to observations
from such inspections.
 Responsible for leading internal audits, customer audits, managing audit findings, maintaining quality
agreements and planning, conducting and documenting periodic cGMP audits of suppliers of raw materials,
packaging materials, contract manufacturers and contract packagers.
 Excel in handling of change controls, preparation of SOPs and training and quality system implantation.
 Handled Mock Recall, In-process Quality Assurance, Batch Release of RM, PM and FDF for Oral Solids,
Regulatory Communication and Compliance
 A logical thinker and observer possessing interpersonal skills, leadership and team building skills.
CORE COMPETENCIES
As an Auditor:
 As an internal Auditor Assist in preparation of audit plan, tracking and review of all audits conducted at site
by internal and external auditors.
 Ensure timely availability of the documents requested the external inspectors and review the documents
prior to submission to inspector.
 Prepare appropriate responses to the observations cited by the health authority inspectors, communicate
internally and monitor the progress of response sent.
 Support to auditors with proper and justifiable explanation to represent the organisation.
As an Investigator and Compliance Specialist:
 A key team member for investigation of customer complaints, deviations, OOS and review, approval and
closure of investigations reports.
 Use of Different Tools for handling and investigation of complaints /deviations/incidents
 Responsible for timely review and respond to the management and the customers.
 Periodic trending of complaints, deviations and developing awareness for reduction of deviations.
As a CAPA Champion:
 Approval and tracking of the CAPA derived for various systems like investigations, internal audit findings
and health authority inspections.
 Ensure and evaluate the effectiveness of CAPA.
As a Team Lead:
 In charge of all the IPQA activities.
 Assist in preparation, implementation of process validation and cleaning validation sampling activities.
 Ensure appropriate and effective implementation of validation report
 Evaluation and review of the process validation reports and validation planned against the validation
master plan.
ADDITIONAL QUALIFICATION
 GreenBeltCertification from International Academy forCertification and Training (Blackbelt Appearing)-2015
 Diploma in GMP; Professional Management Academy, Pune, Maharashtra; First class – 2010
 ORGANISATIONAL TIMELINE
 Current Organisation: Asst. Manager-Glaxo SmithKline Pharmaceutical Limited, India: Oct.2014 to till date
 Previous Organisation1: Sr. Executive- Sandoz Pvt. Ltd. (A Division of Novartis): Apr. 2010 to Oct. 2014
 Previous Organisation2: Sr. Officer- Unique Pharma. Ltd.: Apr. 2008 to Apr. 2010
 Previous Organisation3: Officer- Mepro Pharma. Private Ltd. - Dec. 2005 to Apr. 2008

2. ORGANISATIONAL EXPERIENCE
 Preparation of complaint investigation report through different investigation tools like Fishbone, Process
Mapping, Onion Peeling, 5 Why’s, Brainstorming etc.
 Reporting to Higher Authority, Escalation (through Field Alert) to Management of Critical Incidents,
customer complaints (external and internal) Deviations complaints.
 Involve with tracking, identification and closure of CAPA system
 A Certified Investigator for change management, market complaints, deviations etc.
 Evaluation of Change Controls for the impact assessment of the proposed changes and compilation of the
changes proposed considering the features like scientific and technical requirements, CGMP, cost, capacity
and feasibility of operations
 Responsible for the periodic review of the customer complaints, deviations and change controls
 Planning, conducting and documenting periodic cGMP audits of suppliers of raw materials, packaging
materials, and labelling, contract manufacturers, contract packagers, contract laboratories.
 Derivation of CAPAs with the objective of the improvement of the system towards the Regulatory and
Quality Compliances.
 Input, maintain, and track findings and CAPAs in Track wise and follow-up of Track wise responses /
CAPA status
 Create department specific presentations and dashboard and trending of findings and KPIs to share in
Site Quality Council and Management Escalations
 Responsible forthe timely implementation of the changes or CAPAs in all departments of the plant and
closure of the same.
 Tasks of resolving the technical and Regulatory issues and provides the solutions in a timely way.
 Conduct effective training for my systems to time to time support to HR dept.
 Responsible for Regulatory support, Goods return and Global Reporting
 Preparation and implementation of various SOPs within timeline
 Stellar role in:
o Reviewing and provision of various documents as requested by various Heath Authority Inspectors
visiting the site
o Independently representing to the various Heath Authority Inspectors the systems
 Responsible for preparation for various Audits and document support to the line Manager during various
audits.
 Responsible for timely provision of the data to the regulatory department from site required for various
registrations and variations
 Responsible for Regulatory compliances and regulatory communication
 Handled Mock recalls and Market returns
 Responsible for preparation and execution of the Cleaning validation activities
 Responsible for Preparation and execution of Process validation Protocols
 Responsible for review of Annual Product report and Product Quality Reports pertaining to the
International guidelines
 Responsible for the release of RM, PM, SFG and Finished goods
 Responsibility of implementation of cGMP at shop floor for manufacturing of oral solids

3. EDUCATION
 2013, M. S. in Pharmaceutical TQM; Kuvempu University, Karnataka; First class
 2012, MBA in HRM; IGNOU, New Delhi; First class
 2005, B. Pharm.; Berhampur University, Odisha; First class
 1998, 12th; Khalikote College, Odisha ; Second class
 1996, 10th; MBD High School, Odisha; First class
PROJECTS UNDERTAKEN
Organisation : Sandoz Pvt. Ltd.
Period : Dec’ 12 to Jun’ 14
Title : Reduction of lead time of investigation of Complaints and Deviations and Closure of
investigation of Customer Complaints and Internal Deviations within timeline and No
Overdue
Organisation : Unique Pharma. Ltd.
Period : Jan’ 2009 to Dec’ 2009
Title : Implementation of Training System in Plant applicable to all levels of associates
COMPUTER/SOFTWARE SKILLS
 Well versed with MS Office, MS Outlook and Internet
 Well versed with computer systems like SAP, Track Wise, SCADA, Minitab and SPC
PERSONAL DETAILS
Date of Birth : 19th July 1981
Father’s Name : Sri K. Ganapati Patra
Religion : Hindu
Nationality : Indian
Marital Status : Married
Hobbies : Reading Books, Listening Music
Skills : QuickGrasper, Meticulous, Analytical, Investigative, Research & Review,
Present Address : # 12, Pranav Heights, Murlidhar Nagar, Pathardi Phata, Nashik, Maharashtra,
India –422010
Permanent Address : Narayani Nagar, Post: Kodala, Dist.: Ganjam, Odisha, India -761032
Languages Known : English, Hindi, Odiya, Telugu, Guajarati and Marathi
DECLARATION
I hereby declare that the above information given is true and correct to the best of my knowledge & belief.
Place:
Date: Sanket Kumar Patra