E-Mail: adr81b@r.postjobfree.com / adr81b@r.postjobfree.com Phone: +91-935******* / 942-***-****
RUJUTA LANGADE
Validation Specialist
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Education: B. Pharm. from Goa College of Pharmacy, Goa University and MBA (Production & Finance) from Shivaji University.
Position: Validation Engineer, Organon USA (Remote India) Specialization: 1. Quality Management Systems,Quality Assurance, Quality Control. 2. Commissioning and Qualification
3. Computer Systems Validations
4. Trainings
Years of Experience: 20+ years
Organization/ Designation Responsibilities/ Projects CONTRACTOR/VALIDATION
ENGINEER (REMOTE)
Location: ORGANON, NJ USA
FEB 2022 -APR 2022
Computer System Validation/ CSA: Project for Organon USA
SAAS based software Validation involving
Change Management
SDLC, Agile Methodologies for Learning Management system,
User Requirement specification, Designing, Validation Plan
Responsible for preparation of test script, in HPALM for platform- based software’s
Performing SIT System Integrity testing,
Defect/Deviation Management
UAT User acceptance testing
Scripted and Non-Scripted testing.
For ETQ Reliance, Lab Investigation, CAPA, Deviations, LMS. Preparation of Validation documents and execution of test scripts CONSULTANT COMPUTERISED
SYSTEM VALIDATION at TEVA
Location: Ambernath, Mumbai
April 2021 – Dec 2021
Projects Undertaken:
Computer System Validation: For Teva R & D USA at, Ambernath Mumbai Project management of CSV, CSV trainings and support in execution of CSV activities
Computer System Validation: Teva R & D. Mumbai
Responsible for preparation of Valpack in gALM, Validation through gALM Tool, preparing, developing and implementing strategies; targeting assignments, in Software validation projects run by Global Corporate IT, on behalf of Patel Consultancy USA ( United Biopharma Technologies) for pharmaceutical industry clients such as Teva (R & D) and DI Remediation programme for R & software’s like Labsolutions UV, Labsolutions IR, Tiamo, ICDAS, DAAS Stability Chambers. Preparation of Valpack protocols and reports, handling of Deviations/Defect Management and Change Management. E-Mail: adr81b@r.postjobfree.com / adr81b@r.postjobfree.com Phone: +91-935******* / 942-***-**** RUJUTA LANGADE
Validation Specialist
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Organization/ Designation Responsibilities/ Projects Sr. CONSULTANT
COMPUTERISED SYSTEM
VALIDATION at IQVIA
(IMS AND QUNITILES MERGER)
Location: Hiranandani, Powai,
Mumbai
Jun.2019- Jul.2020
Responsible for developing and implementing strategies; targeting assignments, in Software validation projects run by Corporate Quality Assurance on behalf of IQVIA for pharmaceutical industry clients such as Corporate Lupin, Kalina and IPCA R & D Kandivili. Projects like Electronic Lab Notebook, HPLC (Empower), gap assessment etc.
Lupin : Gas assessment for audit points .
IPCA : Biotech Lab, ELN (Electronic Lab Note book Project) and monitoring the validations at site.
MANAGER QUALITY ASSURANCE
SPIRO LIFECARE PVT. LTD
Location: Chakala, Andheri,
Mumbai
January 2019 to June 2019
• Implementing quality assurance strategy and tracking assignments in support of Metered dose inhaler Quality Assurance Project.
• Review of QA, QC, Production, Engineering SOP in view of setting of new plant.
• Preparation and review of cleaning validation, Process validation, stability protocol. Batch manufacturing record, Batch packing records, QC specifications, Raw material specification for Products planned in view of registration batches and starting commercial production.
ASSISTANT MANAGER
(CORPORATE QUALITY
ASSURANCE), CIPLA LTD.
Location: Vikhroli, Mumbai
August 2017 to January 2019
• Implemented quality measures such as preparation of necessary documents to ensure compliance with
regulatory standards & customer requirements.
• Developing new process concepts for production
optimization & process improvement as well as
guidelines for sequencing of manufacturing activities at the shop floor (SOP).
• Guiding staff on equipment processes, monitoring the performance of team members to ensure efficiency in process operations and meeting of production targets.
• Worked with Corporate Documentation Cell while
managing 10 units and directing all activities of quality control, testing and system releases.
• Established, approved and reviewed documentation, SOPs and action plans of instrument and equipment
using Cipdox Software.
• Responsible for continuous improvement
measurements and implementation.
• Reviewing & approving API / raw material specification, E-Mail: adr81b@r.postjobfree.com / adr81b@r.postjobfree.com Phone: +91-935******* / 942-***-**** RUJUTA LANGADE
Validation Specialist
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Organization/ Designation Responsibilities/ Projects finished product, finished bulk, in-process, volumetric and reagent specifications
• Conducting trials and internal audits / inspections for the quality system including process and hygiene
controls to ensure that quality of incoming products meets specifications.
• Performing Computerized System Validation for new software of Learning Management System and
preparation of rollout installation of software across all Cipla Locations.
• CSV documents preparation and review of URS, FRA, DQ, risk assessment protocol, FMECA, Validation Plan, preparation of IQ, OQ, PQ test scripts, execution of scripts, traceability matrix, summary report, back up & restore, system release and routine periodic review. Site Lab Software Administrator,
Medispray Laboratories Pvt. Ltd
(Sister Concern of Cipla Ltd)
Location: Satara,
Maharashtra
September 1998 to August 2017
• Led and performed computerized system validation of laboratory instruments such as HPLC, UV, FTIR, Karl Fisher Auto-Titrators, Liquid Particle Counter, Total Organic Carbon Analyzer.
• Conducted user management of software and
spearheaded software control activities like password control and revisions, backup of electronic data,
template control of instruments, software up-gradation and CSV validation; performed software activities as per privileges defined in the User Management Policy
document of respective software.
• Worked towards ensuring server data backup is
performed as per the schedule and verified.
• Assigned duties to the Software Functional Head of individual unit for software related activities and reviewed electronic data and IT Security.
• Organized periodic meetings & interactions to provide technical guidance to all laboratory staff.
• Provided guidance on computerized system validation and ensured that the computerized systems are
validated as per 21CFR, GAMP 5.
• Authored, reviewed and approved SOPs such as IOP, EOP, UMCS, DOPCS, DSP, QCP, CQA.
E-Mail: adr81b@r.postjobfree.com / adr81b@r.postjobfree.com Phone: +91-935******* / 942-***-**** RUJUTA LANGADE
Validation Specialist
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Organization/ Designation Responsibilities/ Projects
• Responsible for the following Shop Floor Quality Assurance activities ( 13 yrs)
o Review of overprint checking, line clearances in manufacturing and packing sections and
dispatches
o Managed the generation & flow of
manufacturing and packing records from
production system including Tablet, Dry
Powders, Oral Liquid & Veterinary.
o Served as a Product Registration Cell (PRC)
Member.
o Led activities entailing preparation of master
batch manufacturing and packing records,
issuances of masters, review of batch records
and dispatches, self-inspections, change control
and deviations.
• Managed the following activities:
o Training on instrument / software,
troubleshooting laboratory user issues,
monitoring implementation of Chromeleon
Report Templates, creating new site databases
and software installations.
• Responsible for the following Quality Control activities: o Reviewer site installation documentation for
instruments such as FTIR, FTNIR, UV, Karl
Fischer, Auto Titrator, Dissolution Apparatus,
Hardness, DT and Friability Instrument.
o Review QC Documentation which included
preparation of finished product, in-process
specification and preparation of OOT trend for
finished product.
o Led activities entailing preparation of master
batch manufacturing and packing records,
issuances of masters, review of batch records
and dispatches, self-inspections, change control
and deviations.
Magnachem Pvt. Ltd., Goa
Jan’96-Aug’96
QC Analyst
E-Mail: adr81b@r.postjobfree.com / adr81b@r.postjobfree.com Phone: +91-935******* / 942-***-**** RUJUTA LANGADE
Validation Specialist
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Adel Laboratories, Goa QC Analyst
Jun’95-Nov’95
Simchem Pvt.; Ltd Goa QC Analyst
Aug’94-Jun’95
Education 1998 MBA (Production & Finance) from Shivaji University. 1994 B. Pharm. from Goa College of Pharmacy, Goa .