QA & Validation Specialist with 20+ Years Experience

E-Mail: ******.***********@*****.*** / ********@*****.*** Phone: +91-935******* / 942-***-****

RUJUTA LANGADE

Assist. Manager QA & Validation Specialist

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Education: B. Pharm. from Goa College of Pharmacy, Goa University and MBA (Production & Finance) from Shivaji University.

Position: Assistant Manager QA, Surajlok Chemicals Pvt. Ltd. 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 Assistant Manager QA

at Surajlok Chemicals Pvt. Ltd.

(API & Intermediates R & D)

03 March -Till date

Responsible for preparation of SOP, Preparation of Technology Transfer Document New API and Intermediates and updations in Existing Process changes, Review of Specifications,Stability Protocol review, review of Method validation of Assay, Related substances, OVI etc. Preparation of SOP for Instruments of Laboratory. Regulatory submissions of documents. Assistant Manager QA

at Indeus Life science Pvt. Ltd.

(CRO Formulation Development

and Commercial Manufacturing)

Location: Mulund West,

Mumbai, India.

23 Aug.2022- 2 March 2024.

Responsible for BMR, BPR review, Batch Release.

Computerised System Validation of Lab Instruments, Equipment’s. Handling of Deviations, Change Control, Investigation, Complaint handling. Process validation, Cleaning validation, Stability studies, Risk assessment, Risk assessment Evaluation of Nitrosamines.

Preparation of SOP, Technical Agreement.

Handling of customer Audit compliance.

Review of Analytical Development report, Site Master file, Quality Manual External Lab audits.

CONTRACTOR/VALIDATION

ENGINEER (REMOTE)

Location: ORGANON, NJ USA

(United Biopharma

Technologies/Patel Consultant)

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 E-Mail: ******.***********@*****.*** / ********@*****.*** Phone: +91-935******* / 942-***-**** RUJUTA LANGADE

Assist. Manager QA & Validation Specialist

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Organization/ Designation Responsibilities/ Projects CONSULTANT COMPUTERISED

SYSTEM VALIDATION at TEVA

Location: Ambernath, Mumbai

(United Biopharma

Technologies/Patel Consultant)

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. Sr. CONSULTANT

COMPUTERISED SYSTEM

VALIDATION at IQVIA

(IMS AND QUNITILES MERGER)

Location: Hiranandani, Powai,

Mumbai

Jul.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

• Implementing quality assurance strategy and tracking assignments in support of Metered dose inhaler Quality Assurance Project.

E-Mail: ******.***********@*****.*** / ********@*****.*** Phone: +91-935******* / 942-***-**** RUJUTA LANGADE

Assist. Manager QA & Validation Specialist

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Organization/ Designation Responsibilities/ Projects Location: Chakala, Andheri,

Mumbai

February 2019 to July 2019

• 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, 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 E-Mail: ******.***********@*****.*** / ********@*****.*** Phone: +91-935******* / 942-***-**** RUJUTA LANGADE

Assist. Manager QA & Validation Specialist

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Organization/ Designation Responsibilities/ Projects 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.

• 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,

E-Mail: ******.***********@*****.*** / ********@*****.*** Phone: +91-935******* / 942-***-**** RUJUTA LANGADE

Assist. Manager QA & Validation Specialist

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Organization/ Designation Responsibilities/ Projects 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

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 .

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