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Quality Control Manager

Location:
Aurangabad, Maharashtra, India
Posted:
October 09, 2016

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Resume:

Resume

Permanent Address

Dr. Valsangkar A.D.

Dnyaneshwari Bunglow,

Plot No.4,Gut No.77,

Satara Parisar,

Aurangabad – 431010.

Mob. :(H) 954-***-****/

954-***-****

Email I.D.:acwy32@r.postjobfree.com

Career Objective

To enrich work life and establish my self as a professional individual in Pharmaceutical industry and to meet the challenges with positive attitude.

Summary of Skills and Experience

Personal Skills :Responsible, Individual good communication skill,

Leadership Creative and Resourceful. Passed IELTS.

Professional Skills : I have 20 years experience in the field of Quality control analysis, validation, and setting up of laboratory

Organisation Experience

1)Organization : Wockhardt Ltd.,Biotech Park.

Designation : Astt Manager- Quality control Period :Dec 2007 to

Oct-2015 in Injectable Facility

Company Profile : USFDA APPROVED facility Mfg. of Injectables

and Formulations

2)Organization Cipla Ltd.(E.O.U.)Unit-II

Designation :Quality Control Laboratory –Unit Head.

Period :Aug 2006 to Dec 2007

Company Profile : New Organization set up in order to meet the

EOU GMP Compliances Mfgs of APIs,and Formulations

i.e. solid dosage,Nasals Sprays, Rectal Sprays.

3)Organization : Cipla Ltd.Unit-I

Designation :Management staff officer

Period :Jul 1996 to July 2006

Company Profile :USFDA,UK-MHRA,TGA,ANVISA approved plant Topical,Suppositories, Nasal and Rectal spray.

4)Organization :TTK Biomeds Ltd.

Designation :Trainee CHEMIST

Period :Dec 1993 to Jun 1996.

Company Profile : Mfgrs of Sterile Sutures and LVPS.

Personal Details

Date of Birth : 29/02/1968

Height / Weight : 162 Cms. / 67 Kgs.

Nationality : Indian

Marital Status : Married

Languages Proficiency : English, Hindi & Marathi

Pharma Literacy

Direct Involment In Facing of almost all Regulatory Audits Like U.S.-F.D.A.And

U.K.-M.H.R.A.T.G.A.-Australia. Validations of Microbiological instruments. Adequate Knowledge of Instruments along with I.Q, OQ.PQ .Laboratory Set up Experiences

Especially for E.O.U –Microbiology Laboratory.At Cipla as well as WOCKHARDT

Biotech Park, Cephalosporin and Shendra Plant

Dept head for Octreotide Acetate at WOCKHARDT For E.O.U..

Cross functioning of Microbial lab during Audits At Cipla as well as WOCKHARDT

The plants which I set up for E.O.U,get approval for Regulatory Audits Like U.S.-F.D.A.And U.K.-M.H.R.A.T.G.A.-Australia in Both Above Organization.

Q.C - Job Description (Reviewing of all Documents)

C

1. Leading team of about 20+ microbiologists for working for Sterile product testing, environmental monitoring and purified water.

2.To establish systems/Procedures and ensure implementations in different functions of microbiology, review of test conducted, SOPs, Specifications and standard testing procedures.

3.Evaluation and closure of Deviations, change controls, New document initiation form and its closure and

4.Support to investigation related to microbiology laboratory ( events, out of specification etc.)

5.To review of qualifications and validations protocols and reports and respective raw data related to Microbiology.

6.To review the Analytical data of intermediate and finished product before release

7.To ensure that the changes of specifications /Standard testing procedures are properly evaluated, documented, approved and closed properly.

8.To ensure the stability samples are tested as per the frequency.

9.Ensure that the self-inspection audit is done as per schedule.

10.Ensure the timely validation of the qualification of the other applicable departments

11.External audit coordination and compliance

12.Ensure the compliance of the established procedures

13.To perform the method validations

14.To support the queries related to Microbiology

15.Ensure the qualification/re qualification of the microbiology instrument

16.Reviewing of methodology.

17. Comparison of water Testing with our IP/EP/BP and USP.

18. Training to all new entrants

19. Yearly/Six monthly steam Sterilisers/Dry Heat Steriliser Validation

FDA Approved and PH.D.

Area of Interest :Quality Assurance or Drug Regulatory Affair

Note:Oversite approved Trainer for QC/Q.A/C.Q.A

Educational Qualification.

M.sc.-Biotechnology M.sc.- Microbiology

Awards-PhD- Microbiology Achievements-F.D.A Approved-Indian Food and Drug Administration.

Reporting to D.G.Manager –Q.C. Alternative Reporting to G.M –Quality Head..

Current CTC -1060000/P.A Expected CTC-Negotiable

Relieving Notice Pay:NA Date:03/10/2016

Place: Aurangabad Dr.Aditya.D.Valsangkar



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