Quality Assurance Control
Resume:
UMAJI BHALCHANDRA REDKAR
A* / ***, Nirman Park – 2 Santoshimata road, Kalyan (W),421 301, phone : 025*-*******,986-***-****
Email : ************@*****.***.
SUMMARY OF EXPERIENCE:
I am having more than decade experience in chemical and pharma industries with proven
multidisciplinary exposure in Quality control, Analytical R&D, Quality Assurance and Regularity
affairs. Effectively managed/associated and faced a number of regulatory a s well as customer
audits during the span of the career. This also includes establishing various functional
departments/teams, developing them and directing as per the organization’s goal and objectives.
Significant knowledge of current good manufacturing practices (cGMP), current good laboratory
practices (cGLP), International Conference on Harmonization (ICH), W orld helth organization
(WHO),Food and drug administration (FDA), ISO standards.
Familiar with the validation, calibrations, troubleshooting and handling of sophisticated instruments
like GC, HPLC, HPLC-GPC, GC-MS, LC-MS UV, AAS, HPTLC, IR, FT-IR. Conversant with
analysis of specific problem. Sufficient experience in maintenance of laboratory equipment,
maintaining of lab records and analytical method development and validation.
Experience in implementation of quality management systems for process unit and review through
internal audits, deviation, change control, internal and external complaints, FIFO systems, OOS,
HACCP and training.
Certified Quality auditor with proven ability to manage internal, vendor, client, and regulatory
audits.
Known for successful implementation of corrective and preventive action program (CAPA)
including with deviations and complaints. Excellent communication, organization and training skills.
ACHIEVEMENTS:
Successfully faced USFDA, MHRA, EDQM, KFDA W HO Audits .
Successfully established ISO 9000:2008 systems.
Successfully faced customer audits from Proctor and Gamble and Unileaver
Successfully conducted number of vendor audits
Approval of change control and deviation.
Ensured the regulatory and quality assurance compliance of the manufacturing units by
periodic review and auditing.
Evaluated suitability of the specification and testing parameters for designing specifications of
APIs.
Review of Analytical method validations, process validations and stability data.
.
page 2
RELATED WORK EXPERIENCE:
Quality Assurance Manager, National company for suphur products, Riyadh, Saudi Arabia.
May 2008 till now.
Head Quality department .
Created new companywide quality assurance process .
Successfully established ISO 9000:2008 systems.
Lead auditor and QMR for company
Successfully pass Audits from EDQM and KFDA.
Created SMF for company.
Design /setup new central quality control laboratory.
Carried out equipment and process validations.
Initiated actions to prevent the occurrence of any nonconformities.
Identified and recorded any deficiencies.
Investigate quality assurance issues.
Monthly reporting to management on QA systems.
Evaluations of Key performance indicators.(KPI)
Water system validation.
Sanitization and cleaning validation.
Qualification, validation and calibration of key equipment.
Finalization of preventive maintenance program.
Monitoring FIFO sytem for Raw material and Final product.
Compliance of storage conditions.
Control of third party manufacturing.
Ensure that all policies procedure,forms,docments,records etc. remain controlled.
Handle the audits in house, customer and government agencies.
Handle customer complaints.
Annual product quality review.
Assisted in safety policies and procedure to improve company’s safety program.
Develop and validated analytical test methods base on GC and HPLC.
Quality Assurance Manager, PharmaBase India limited, Ambernath, India. March 2006 to April
2008
Handle Quality Control and Quality Assurance Department.
Design and develop quality control laboratory.
Carried out selection, installations and validations of QC equipments.
Carried out equipment and process validations.
Lead CAPA program.
Identified and recorded deficiencies.
Housekeeping
Cleaning validation.
Customer complaints handling.
Investigate quality assurance issues.
Vendor development and approval.
Carried out internal and vendor audits.
Faced regularity audits from MHRA,USFDA,WHO,FDA India
Annual product quality review.
Page 3
Incharge QA/QC, Modepro india privet limited, Turbhe, India. July 2005 to March 2006
Heading quality control department.
Supporting R & D for analysis.
Assisting MR for ISO documentation.
Overtaking of batch sheets.
Finished product consignment cheking.
Analysis of Raw material, in process and finished products.
Handling of sophisticated equipments like GC, HPLC, UV.
Executive QA/QC, Hikal limited, Taloja, India. September 1998 to June 2005
Preparation updating and review of batch sheet formats and sops.
ISO 14000 and 18000 documentation.
Issuance of batchseets.
Overtaking of batch sheets.
Finished product label control.
Finished product consignment cheking.
ISO 17025(NABL) documentation.
Analysis of Raw material, inprocess and finished products.
Handling of sophisticated equipments like GC, HPLC, UV, IR.
Chemist QA/QC, Herdillia limited, Navi Mumbai, India. May 1991 to June 1998
Analysis of raw aterial intermediate and final product.
Co Ordination with process department.
Handling of sophisticated equipments GC,HPLC,UV IR AAS.
ISO 9000 documentation.
ISO 17025(NABL) documentation.
Analytical Chemist, GEO-CHEM Laboratories, One year.
Analytical Chemist, Bee-pharma Laboratories, One year.
Analysis of pharmaceutical finished product, Raw materials, Intermediates as per different type
of pharmacopeia such as IP,BP,USP,JP and as per customer specifications or test methods.
Handle instruments such as GC, HPLC, HPTLC, UV, and IR.
EDUCATION:
ISO certified Auditor.
Basic computer programming diploma.
B Sc. Chemistry from Mumbai University.
Date of Birth : 25 August 1965
Contact this candidate