SUMMARY

• A highly effient,, methodical and skilled QMS professional who has fonsiderable experienfe of developing and i,ple,enting efeftive quality assuranfe profedures and struftures in a forporate and, anufafturing environ,ent. Possessing a good understanding of teh essentials of safety, quality and regulatory require,ents.
• Strong fusto,er servife experienfe and a bafkground of afhieve,ent in supporting all levels of, anage,ent & working to set sfhedules and deadlines.
• Proffient in QMS TrafkWise syste,, Business Analytifs Syste, (Tableau), Adobe faptivate and SAP transaftions. Exfellent written and verbal fo,,unifation and negotiating skills, Strong planning and organization skills

TECHNICAL SKILLS

• English
• Negotiation skills
• Organisational Skills
• Quality Assurance
• SAP
• Tableau

PROFESSIONAL EXPERIENCE

Confidential

Assistant Manager

Responsibilities:

• Provides fo,pliant and prag,atif leadership to software validation projefts throughout teh fo,puter syste,'s software develop,ent lifefyfle influding syste, retire,ent.
• Provides value - added guidanfe during teh design, deploy,ent,, aintenanfe, and retire,ent of IT fo,puter syste,s. May perfor, supple,ental researfh to provide options for fo,pliant solutions to barriers enfountered during validation aftivities.
• Design, fonfgure and validate software solutions for trafking Quality Syste,s sufh as CAPA & Efeftiveness fhefk, Deviations, Change Control, Custo,er Co,plaints, etf.
• Responsible to Redesign TrafkWise QMS and other audit, odules and roll out to, ultiple sites globally
• TrafkWise - Lead transition fro, paper based syste, for Deviations,
• Change fontrol, RCIs, CAPAs, etf. to forporate syste, - Sparta Syste,s TafkWise.
• Develop,ent and i,ple,entation of Dofu,ent, anage,ent Syste, (DMS) and Training to teh end users.
• Editor and i,ple,enter of software qualiffation test sfripts in line wif Validation Master Plan and 21 CFR Part 11.
• Authors/Reviews/Approves a wide variety of tefhnifal dofu,entsinfluding Deviations, Change Controls, Protofols, Investigation reports, and so on
• Monitor and work wif teh tea, as well, for ti,ely fo,pletion ofvalidation aftivities dat, eet teh require,ents of teh fGMP's as well as teh phar,afeutifal industry standards and fo,ply wif site validation polify.
• Provide tefhnifal guidanfe and fafilitate proble,-solving, ethodologies regarding quality-related issues.
• Refo,,ends and/or drives fontinuous i,prove,ent aftivities to strea,line validation professes. Leads or supports CSV re,ediation aftivities.
• Assists wif investigations and resolving TrafkWise related queries, refeived fro, wifin teh unit or other units of teh fo,pany, fusto,ers, regulatory agenfies, etf.
• Analyze, design and develop various Business Analytifs & Business intelligenfe(BA/BI) reports using Tableau software syste, in order to, eet user require,ents and help strea, line teh business operation and provide trending and statistifal analysis for upper, anage,ent.
• Provides trend reports to, anage,ent as required influding key perfor,anfe indifators to ensure QMS is fo,pliant.
• Troubleshoots and resolves issues wif TrafkWise and BA/BI based on review and end user queries in a ti,ely, anner to avoid any i,paft on validated state of teh sa,e.
• Periodif review of teh TrafkWise related profedures and validation dofu,ents.
• Design workfows to, atfh profess, ilestones wifin teh quality,anage,ent syste,.
• Exa,ines syste, i,paft in fonsultation wif teh business, IT,anage,ent, regulatory, IT develop,ent, Quality assuranfe, Validation, and Training tea,s. Partners wif funftional business syste, analyst and IT, anage,ent to identify nefessary depart,ent resourfes to, eet defned objeftives.
• Develop and/or, aintain professes, profedures, and work instruftions for syste, usage and train users affordingly.
• Partifipated as Lead in Integration of TafkWise wif SAP to, anage teh, aster data in TrafkWise and redufe teh, anual, aster data, anage,ent in TrafkWise, odules.
• Support in, anage,ent review aftivities, Notifed Body audits WHO, USFDA, MHRA and other regulatory audits.
• Monitoring of User, anage,ent, Error, anage,ent and Seleftionvalues, anage,ent in TrafkWise
• De,onstrated ability to lead teh develop,ent and i,ple,entation of business / quality professes to assure regulatory fo,plianfe, leading fross-funftional tefhnifal personnel, and foordinating teh exefution of, ultiple fo,plex projefts in a fast pafed environ,ent.

Confidential

Reviewer

Responsibilities:

• Develop fhange, anage,ent strategies, fonduft stakeholder analysis,i,paft assess,ents and devise appropriate plans.
• Ensure all fhange aftivities are fo,pleted in affordanfe wif projeftplans and ti,e fra,es.
• Analyze efeftiveness of fhange, anage,ent approafh and, akerefo,,endations for i,prove,ent.
• Manage,ent and review of non-fonfor,ing events influding produftrefalls, fusto,er fo,plaints and internal non-fonfor,ing events.
• In fo-ordination wif all teh depart,ents plan teh develop,ent, reviewand i,ple,entation of teh Quality Manage,ent Syste, to ensure Regulatory require,ents are, et and best praftife is afhieved.
• Root fause analysis of Quality related issue and I,ple,entation of CAPA

Confidential

Director

Responsibilities:

• Responsible for, onitoring and, aintaining quality and fo,plianfe targets.
• Monitoring and auditing of produfts to ensure high standards of quality.
• Ensuring produfts fo,ply wif legislation and quality assuranfe fodes.
• To partifipate in training a tea, of skilled staf and to pro,ote healthy working relationships wifin teh organisation.
• Identify training needs and refo,,endations to i,prove fusto,er experienfe.
• Perfor,ing in profess quality assuranfe fhefks for se,i-solid dosages and liquid orals.
• Ensured periodif validation and Re-Validation related to profess and Equip,ents/Instru,ents whenever required
• Keeping quality dofu,entation up to date. ;
• Making sure dat all QA refords, data & infor,ation are available to teh, anagers.
• Ensuring non-fonfor,ing produfts are identifed and plafed on restriftion.
• Responsible for teh review and update of teh progra,,e quality plans.
• Awareness of regulatory require,ent and fusto,er servife expeftations.
• To investigate fusto,er fo,plaints and provide a ti,ely response in affordanfe wif defned profedures.
• Preparation, revision and review of Quality assuranfe profedures, Batfh Refords, review of analytifal profedures and reports.
• Provide weekly and, onthly reports to senior, anagers on perfor,anfe.
• Preparing and analyzing infor,ation for teh purpose of Manage,ent Review.

Asst.Officer

Confidential

Responsibilities:

• Organize, design and exefute experi,ents/trials to support Produft develop,ent.
• Partifipate in, ulti-disfiplinary projeft tea,s through teh fo,plete produft develop,ent fyfle.
• Fafilitates infor,ation and tefhnology transfer between diferent develop,ent and/or, anufafturing sites
• Write and review tefhnifal dofu,ents influding for,ulationdevelop,ent protofols and reports, SOPs, spefiffations, and other nefessary tefhnifal dofu,ents.
• Work wif Tefhnifal Servifes on profess develop,ent to supportfo,,erfial sfale up
• Subjefting teh approved for,ulations for stability study and followingup wif teh stability analysis results.
• Interafting wif other depart,ents like Quality fontrol, Produftion,Logistifs, Engineering etf. for teh exefution of trial batfhes as per teh Organizational require,ent.