Sankalpa Sucharita

• Collaborated with QA team to test software quality through manual and automated testing.
• Teamed on planned tests and time-sensitive ad hoc requests.
• Defined and identified test cases for new application development.
• Hands on experience in creation and review of Validation deliverables like Validation Plan, Protocol, Test Cases, Traceability Matrix, validation summary Report)
• Drafted test scripts, Prepared test scripts for test execution, Performed quality review of test scripts.
• Authoring and Execution PQ and OQ for system validation
• Hands on Experience in Preparation of configuration specification documents,Validation Plans
• Hands on experience in Quality and Facility Management tools like STEP and Tulip
• Hands on experience in RIMS tools like Register, LSRIMS and Veeva RIMS
• CSV Knowledge of GxP environment with experience in validation life cycle and V-Model
• Participated in different regulatory client based and internal Audit
• Better understanding of GAMP 5, CFR part 11 and EU Annex 11
• Hands on experience handling requirement, testing and deviation in HP ALM and ADO testing tool

• Partnered with project team members to identify and quickly address problems.
• Facilitated workshops to collect project requirements and user feedback.
• Reported regularly to managers on project progress, and technical problems.
• Verified quality of deliverables and conformance to specifications before submitting to clients.
• Hands on experience in applications like Argus, Eclipse, G360, Veeva RIMS and sales force
• Qualification, verification and review of above mentioned applications
• Defect management in HPALM tool
• Experience in authoring ITRA, Validation plan,validation report, Traceability matrix doc and protocols

• Developed custom solutions based upon clients' strict requirements.
• Evaluated clients' needs and created plan of action to provide solutions.
• Troubleshot issues by understanding issue, diagnosing root cause and coming up with effective solutions.
• Assessed needs for projects and made proposals to senior executives.
• Exceeded customer requirements with accurate and deliverable solutions.
• Identified key areas in need of improvement and implemented plans to rectify issues.
• Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
• Optimized customer experience by delivering superior services and effectively troubleshooting issues.
• Worked as Consultant in roles in business services with focus on computerized system validation (CSV) engagements for life sciences clients
• Hands on experience in RIMS tools like Register, LSRIMS and Veeva RIMS
• Hands on experience in preparation of device SOP (DISP) , PQ, OQ, Work Instructions and PPTs
• Preparation of SOPs and Work Instructions for processes like CE Mark, PMDA-

Shonin, PMDA-Ninsho, FDA-510 (K) and Device change submission management

Provides CSV support to Regulatory software used by clients

E-learning Module Preparation and Instructor Led Training (ILT) material preparation for RIMS and internal training delivery based on different Regulatory Processes

Gap Analysis between Business Processes

Knowledge on ‘IDMP' o Involved in projects like CURD (Creating, Updating, Replacing and Deleting) and Data quality and root cause analysis

Advanced MS word formatting skill utilized in DQ analysis, authoring of SOP (ISP &

DISP) and validation documents

o Participated in different regulatory client based and internal Audit

o Better understanding of GAMP 5, CFR part 11 and EU Annex 11

• Monitored unit training and training schedules.
• Review of BMR and BPRs
• Daily review of Shop floor activities and logbooks for correctness
• Implemented innovative programs to increase employee loyalty
• Launched staff engagement, gender diversity and cultural programs in addition to robust reporting tool that increased operational quality.
• Involved and addressed regulatory audit review points
• Ensure documents used in pharmaceutical production shopfloor are regulatory compliant
• Aligning with QA personals to review and update SOPs as per current requirement
• Handling process related deviations occurs during production operation