CAREER OBJECTIVE:-

To grow into mature and experienced individual with each passing day in a professionally managed organization always contribute towards progress of

organization with best of my potential.

WORK EXPERIENCE:-

Presently working with Sun Pharmaceutical Industries Limited, Dahej (Gujarat) in QA API since Jun 2021. Current position: Senior Executive.

CURRENT JOB PROFILE:-

Review and approved of the SOPs and finding gaps.

Handling of Process Validation and Cleaning Validation Protocols and Reports.

Handling of Qualifications ( Equipment, Facility, Utility, Water system and HVAC) protocols and reports.

Handling of Deviation, OOS/OOT Investigations .

Handling of Product quality complaint and its CAPA.

Handling of plant and microbiology department compliance.

Review CAPA,Change Control and Risk Assessment Management.

Co-ordinate Internal audits and its compliance.

Annual product quality review Prepared and review .

Control Sample management.

Review and approved MPCR and MECR and its issuance management .

Actively participate in Regulatory and customer audits..

Handling of SAP, LIMS, EDMS, e- BMR ( BRMS), LMS and Track Wise software.

Conduct training on GDP, GMP refreshment and data integrity awareness for manufacturing and QC persons.

Batch release/ reject in LIMS and SAP and Analytical data review.

PREVIOUS ORGANISATION:

Organization: Glenmark Life Sciences Limited,Ankleshwar (Gujarat). Earlier this organization was named as Glenmark Pharmaceutical Limited.

Designation: Executive ( July 2017 to Jun 2021 )

Job Profile:

Preparation of Annual Product Quality Review report.

Review of Out of trend & Out of specification test results.

Handling of Change Control proposals in SAP .

Handling of Deviations.

GMP Round in Manufacturing & Powder processing area.

Handling of site IPQA QA team.

Organization: Alembic Pharmaceutical Limited, Vadodara (Gujarat)

Designation: Executive ( July 2015 to July 2017 )

Job Profile:

Preparation of Annual Product Quality Review report.

Handling of Change Control and temperory change control.

GMP Round in Manufacturing & Powder processing area.

Return goods, inspection and release activities.

Handling of SAP and DCS (Documentation control system) software.

Organization: Unichem Laboratories Limited Pithampur Indore (M.P.)

Designation: Officer (August 2014 to July 2015 )

Job Profile:

Preparation of Annual Product Quality Review report.

Review Out of trend & Out of specification test results.

Handling of Change Control proposals.

Handling of Deviations.

Review of Process & cleaning validation protocol & report.

GMP Round in Manufacturing & Powder processing area.

Return goods, inspection and release activities.

Review of Batch Production and Control Records in line with regulatory aspect.

Handling of SAP and LIMS software.

Organization: Ipca Laboratories Ratlam (M.P.)

Designation: Chemist (GMP- Coordinator) in Production dept. (July 2012 to August 2014)

Job Profile:

Toperform cleaning validation and manufacturing process, equipment qualification, Holding time study, under Co-ordination with QA.

Reporting of all deviations observed during manufacturing of products, it's

investigation and implementation of corrective actions to avoid recurrence.

Investigation of batch failures i.e. OOS, OOT, product complaint.

Initiation, implementation and closure of change controls.

To coordinate in internal/external audits and compliance of audit observations.

To ensure the calibration of weighing balance and pH meter.

To ensure the cleaning and sanitization of the product facility.

Training on GMP, SOP and manufacturing process to production staff.

Preparation and review of documents i.e. batch records, SOPs, Master documents, protocols, reports and all documentation.

Handling of SCM (Supply Chain Management) computer software.

TRAINING PROGRAM ATTENDED:-

Four Month Project Training completed on “MLT (Microbial Limit Test)” In ALPA Laboratories limited AB road rau Indore M.P. (January-2009 to April- 2009) .

Successfully completed training on “Data Integrity” as per training Program in Glenmark Pharmaceutical limited Ankleshwar (15th October.- 2017).

Successfully completed training on “Data Protection & Privacy” as per training Program in Glenmark Pharmaceutical limited Ankleshwar .( 28th Jun.- 2019).

Successfully completed training on “ How to Use Learning Management System” as per training Program in Glenmark Pharmaceutical limited Ankleshwar .( 6th November.- 2019).

Successfully completed training for "LEAN SIX SIGMA YELLOW BELT CERTIFICATE" from Effort consultant Aug-2021.

Successfully completed Training for " ISO9001:2015 QUALITY MANAGEMENT SYSTEM LEAD AUDITOR " from UDEMY California USA (Jun-2022.)

Successfully completed training for "LEAN SIX SIGMA GREEN BELT CERTIFICATE" from VALUE enablers Academy Aug-2022.

Successfully completed Training for " INTEGRATED MANAGEMENT SYSTEM (IMS) I.e. ISO9001,ISO14OO1 &45001" from Alison (Oct.-2022)

ACHIEVEMENTS:-

"PROCESS EXELENCE AWARD- 2019” received from Global Quality Head of

Glenmark Life Sciences Limited Ankleshwar Gujarat.

“BEST QUALITY TEAM AWARD- 2020” received from Global Quality Head of Glenmark Life Sciences Limited Ankleshwar Gujarat.

USFDA, WHO, CDSCO, ANVISA, COFEPRIS, HEALTH CANADA,EDQM, MHRA and PMDA and Customer Audit exposure .

Four “SPOT AWARD” received from Glenmark Life sciences Limited Ankleswar Gujarat.

EDUCATIONAL QUALIFICATION:-

M.Sc. with (62.37%) first division in year 2009 from Vikram University, Ujjain (M.P.)

B.Sc. with (57.38%) second division in year 2007 from Vikram University,Ujjain (M.P).

Higher Secondary with (65.55%) first divisio in year 2004, M.P Board, Bhopal (M.P).

High School with (69%) first division in year 2002, M.P Board, Bhopal (M.P).

COMPUTER SKILLS:-

Diploma in Computer Application (DCA), MS Word, MS Excel, MS Power Point, Working of Internet and basic fundamentals of computer.

STRENGTH:-

Punctual.

Team work

Time Management

Self Direction

PERSONAL PROFILE:-

Father’s Name :

Shri B. L. Malviya

D.O.B. :

12/12/1986

Permanent Address :

B- 211, Vaibhav Park society, Valiya Road GIDC,Ankleshwar Gujarat 393002

Language :

English, Hindi and Gujarati

Gender :

Male

Marital Status :

Married

Hobbies :

Reading, Playing carom, Making New Friends.

Total experience :

10 Years 4 Months

Current CTC :

8.74 Lakh/Year

Notice Period. :

3 Months

REFERENCES:-

Mr. Mahendra Patle

GM Quality Assurance

Ipca Laboratories Ltd. Ranu, Vadodara ( Gujarat)

Mob. No. - +91-704**-*****

Mr. Fergus Gonsalves

DGA-CQA

Unichem laboratories ltd. Goa.

Mob. No. - +91-991**-*****

DECLARATION:-

I hereby declare that above mentioned information is true to the best of my knowledge.

Place: Ankleshwar (Gujarat)

Date :

Shyam Malviya

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