RESUME

RASHID RASULSAB MUNJEWAR

Contact : (M) 088********, 087********

Email id : acde3h@r.postjobfree.com

JOB PROFILE / ACHIEVEMENTS :

I am a seasoned professional in pharma and API manufacturing industry, having

17+ years of hands-on experience in QC, QA, Regulatory and presently a key member of

senior management.

Devised QC systems, prepared SOPs, STP, and Analytical Method Validation,

Cleaning Validation and Purified Water Validation. Qualification of Equipment and

Instruments.

Having experience to face EDQM, TGA, WHO, MHRA, USFDA audits and also

successfully faced the international customer audits.

Responsible / looking after all QC related jobs directly through the functional heads.

Implemented QC systems as per ICH-Q7, 21 CFR guidelines etc.

WORK EXPERIENCE : 17 Years 3 months

Dr. Datsuns Labs Ltd, Mahad ( Formerly known as AANJANEYA

1.

LIFE CARE ) : Since 21 Mar 2012 working as “Senior Manager –

th

Quality Control”.

2. IPCA Laboratories Ltd, Aurangabad : Since 10th Feb 2011 to 18th

March 2012 worked as “Manager Quality Control” and as a site QC

Head at Waluj, Aurangabad.

AMRI India Pvt Ltd, Aurangabad ( US Based Company ):

3.

(Certified by TGA, WHO, EDQM)

Since 10th Oct 2005 to 9th Feb 2011 as “Asst. Manager Quality Control”

as a site QC Head at Waluj, Aurangabad.

Looked after all QC activities of AMRI India Pvt. Ltd. and reporting to Director-

Quality Assurance & Regulatory Affairs.

Successfully faced the TGA and WHO audits (two times), EDQM audit in AMRI

and got approval without having any major non compliance.

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Implemented Quality systems (as per ICH Q7) and prepared following documents

of AMRI at Aurangabad.

For all QC related work prepared various SOPs, STPS, and GTPS etc.

Training provided for all sub-ordinates on “Good laboratory Practices (GLP)”

Assist & co-ordinate with regulatory dept. for preparation of Draft- DMF.

Familiar with data handling with reference to Q. C. documentation like Protocols,

Analytical Reports, Certificate of Analysis etc.

Prepared various protocols for Validation of Assay by HPLC, Related substance,

Residual Solvents and residual reactants.

Helping Regulatory Affairs for preparation of DMF(s), customer queries etc.

Successfully faced various customer audits (International / Indian) for e.g. Sanoffi-

Aventis, Astra Zeneca, Ratiopharm, I-Vax, Zydus Cadila, Nicholas Piramal etc.

US-FDA DMF Preparation was completed by me and audit preparation activity is

going on.

Specifications and Standard Test Procedures (STPs) for all incoming Raw materials,

intermediates, in process, and finished product etc.

Stability studies as per ICH Guidelines.

Analytical Method Validation of Related Substance, Residual solvent, Residual

Reactant, Assay etc.

Preparation of working standard against Reference standard.

Analysis of Finished products, Raw materials and Packing materials.

Analysis of Tablets.

Maintenance and calibration of instruments and its records.

Preparation and review of Analysis reports for RM, IPQC, Intermediates and FG

etc.

Generation of Working Standard and maintained records.

Handling of Market Complaints and required analysis work.

Sr.

Name of Instrument Make

No.

1 HPLC Spectra series, Water, Varian, Jasco, &

Shimadzu, Thermosepration.Agilent

Isocratic & Autosampler.

2 G.C. Perkin, Shimadzu, Netel Chromatograms,

Chemito & Data Labs,

Agilent Headspace.

3 I.R Buck Scientific

4 U.V. Shimadzu 160A,/ 1800

5 Autotitrator Metro ohm, Mettler & Veego.

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6 Karl Fischer Veego

7 Polarimeter, Bulk Density Datalab

8 Melting Point Apparatus Remi Equipments

9 FTIR Gasco /Shimadzu.

10 Dissolution Apparatus Datalab

11 Malvern Malvern -2000S

Kopran Limited, Mahad :

4.

(Certified by EDQM, WHO)

Since 4 th July 2000 to 9th Oct 2005 at Mahad Dist. Raigad as “Senior Executive - Quality

Control”.

Successfully faced EDQM audit and got approval.

Preparation of documents.

Stability indicating method, Forced Degradation of API.

Handling of Deviation, Change ControlI investigation and CAPA.

All QC activities as described above.

Handling of instruments.

5. M/s. Thai Chem Pharma Pvt. Ltd. (API Unit), Mahad :

Since Dec-1996 to Jun-2000 as “QC Officer” at Mahad, Dist. Raigad.

Worked on following products:

Ceftazidime, Amlodipine Besylate, Atenolol, Ceftriaxone Na Sterile,

Cefotaxime Na Sterile, Cefoperazone Na Sterile, Roxithromycin, Azithromycin,

Panomer, Cefadroxil, Tramadol Hydrochloride, Silenafil Citrate, Omeprazole

Pellets, Furosemide, Metformin HCl, Venlafaxine HCl, Propranolol

Hydrochloride, Atorvastatin Calcium, Clarithromycin, Clarithromycin Granules, Warfarin sodium, Lumefenterene,

Flumequine, Metoprolol Tartarate, Pyrental Pamote, Metoclopyramide

Hydrochloride, Chloronthiadone, Quinine sulphate, Bromhexine Hydrochloride

etc.

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Personal Profile

1. NAME : RASHID RASULSAB MUNJEWAR.

PERMANENT ADDRESS : Basera Apartment, Flat No 13, Near

2.

Nehru Bhavan, Buddi line

Aurangabad

– 431001

Maharashtra (India)

Phone No.: 088******** (M)

087******** (M)

PERMANENT ADDRESS : At: Omerga(y), Post: Chapoli.

3.

Tq: Chakur, Dist: Latur.(MH)

Pin 413513.

DATE OF BIRTH : 06 th May, 1970

4.

EDUCATIONAL QUALIFICATION :

5.

M. Sc. (Chemistry)

MBA (Total Quality Management)

Research work completed in Development and Validation of Analytical

Methods For Pharmaceutical Products (Thesis submitted to JJTU Rajasthan).

Maharashtra FDA Approved (Testing and Instrumentation).

COMPUTER KNOWLEDGE : Working knowledge of MS Office.

6.

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NOTICE PERIOD : one Month.

7.

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