Deputy Manager

S. A. GAFUR

Quality Control Professional

+91-903*******, 991-***-**** I ***************@*****.*** I Bengaluru, INDIA Linkedin.com/in/shaik-abdul-gafur-239294209

PROFESSIONAL SUMMARY

Energetic and product focused, quality oriented analytical specialist with more than thirteen years of experience in the pharmaceutical environment. A well-versed knowledge in qualitative and quantitative analysis. Senior level experience in internal quality functions and with understanding of current regulatory expectations.

AREAS OF EXPERTISE

Roles and Responsibilities

● Experience in the Quality Control Department, with Instrumental & wet analysis and good exposure on the equipment used in the Quality Control with LIMS (Calibre and Labware) documentation practices.

● Review of Documentation for finished products, Intermediates and Raw materials

● Electronic data review and Audit trials verification of analytical instruments.

● Responsible for GLP,GDP and laboratory compliance.

● Handling of Deviations and OOS results investigations for Intermediates, finished products.

● Good Knowledge on Trackwise for Deviations, Change controls.

● Initiating change controls on revision of SOPs.

● Working Knowledge with Labware (V:7) LIMS and Masters knowledge in Calibre LIMS Module.

● Laboratory incident Investigations.

● Preparation of Protocols, Reports and Technical documents.

● Knowledge on Analytical Method Validations.

● 5S implementation for record archivals and ensure the upkeep of Laboratory instruments.

● Good Exposure on Chemical and Instrumental analysis for finished Product and Raw Materials.

● Analytical Instrument Qualifications (URS, Validation plan, DQ,IQ,OQ,PQ) and CSV(GAMP5).

● Troubleshooting and Calibrations of various instruments like HPLC, GC, UV and IR etc.

● Organised for qualification of Working Standards, and Internal Reference Standards.

● Responsible for Calibrations and Preventive Maintenance as per a planned schedule.

● Ensure timely training of all QC personnel as per the training schedule.

● Ensure the availability of all required chemicals, columns and any other miscellaneous items and their approval for procurement.

● Demonstrative role in the audits, audit compliance and regulatory audit exposure in USFDA, MHRA, EDQM, TGA, H.C.

WORK EXPERIENCE

BIOCON LTD I Deputy Manager I Bommasandra, Bangalore I Dec 2019 – Present NATCO PHARMA LTD I Executive Level E1 I Shadnagar,Hyderabad I May 2018 – Dec 2019 APOTEX PHARMACHEM LTD I Jr Manager I Bommasandra, Bangalore I May 2015 – Apr 2018 MYLAN LABORATORIES LTD I Officer I Jedimetla, Hyderabad I May 2013 – May 2015 Dr. REDDY’s LABORATORIES LTD I Team member I Miryalguda, Hyderabad I Aug 2007 – May 2013 S. A. GAFUR

Quality Control Professional

+91-903*******, 991-***-**** I ***************@*****.*** I Bengaluru, INDIA Linkedin.com/in/shaik-abdul-gafur-239294209

INSTRUMENTS HANDLED

HPLC I Shimadzu HPLC-2010 CHT and Agilent with Software Empower-3. GC I Shimadzu GC (Model 2010, 2014), GC Solutions and Agilent with Software Empower-3. Wet /Solid Lab Instruments I UV (Perkin Elmer),IR (Thermo, Perkin Elmer),KF (Metrohm Auto titrator), Malvern Mastersizer 2000, XRD (Xpertpro PAnalytic), SOR (Rudolph Autopol-V),NMR

(Bruker),etc.

EDUCATION

Master of Science in Analytical Chemistry I Sri Venkateswara University, Tirupathi I March 2011. Bachelor of Science in Mathematics, Physics, Chemistry I Andhra University, Vizag I March 2003. Intermediate (10+2) Mathematics, Physics, Chemistry I IPE, Vizag I March 1998. SSC (10+2) I Vizag I March 1996.

TECHNICAL SKILLS

Certificate in Computing - IGNOU I Vizag I 2007.

Post Graduate Diploma in Computer Applications (PGDCA) I Vizag I 2003. Institution of Occupational Safety and Health (IOSH) I NIST Hyderabad I 2012. PERSONAL PROFILE:

Name : SHAIK ABDUL GAFUR

Date of Birth : 01-02-1981.

Father name : SHAIK ABDUL SAHEB.

Sex : Male.

Marital status : Married.

Languages known : Telugu,English, Hindi and Urdu. Nationality and religion : Indian and Muslim.

Permanent Address : 17-2-981/A, Rein Bazar, Madannapet, Syedabad, Hyderabad, INDIA PIN 500023

DECLARATION:

I hereby declare that the information presented by me above is true to the best of my knowledge. Date:

Place: Bengaluru, India Shaik Abdul Gafur

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