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Pharma QA

Location:
Indore, MP, India
Posted:
February 27, 2017

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Resume:

KAUSHIK GUPTA

PERMANENT ADDRESS:

Rehara Chungi, Vindhyachal,

Mirzapur (U.P.)

Contact No.:096********, 708-***-****

E-mail: acy0wf@r.postjobfree.com

Career Objective.

*I wish to employ my learning ability to know new technologies and achieve consistent uphill success in my professional career by effectively leveraging out my skills both technical and interpersonal and achieve success of organization.

Work Experience.

* Working in Quality Assurance section as Scientific Officer (VACCINE plant) since November 2015to till date at PANERABIOTEC(sister concern of PANACEA BIOTEC),LALRU,Mohali,PUNJAB.

* Worked in Quality Assurance section as Senior Officer QA since March 2014 to September (1.6yrs) 2015 date at THEON Pharma LTD., Nalagarh,Solan,H.P.

* Worked in Quality Assurance section as QA Chemist July 2011 to Feb 2014 (2.8 yrs.) at Skymap Pharma, Roorkee, Haridwar,U.K..

Job Profile

Job Responsibility in PANERA BIOTEC

1. Inspection and verification of In-process activity in Vaccine Manufacturing Area.

2. Routine Visit of Quality Control Lab, Animal House, Microbiology Lab and warehouse for assurance of non-compliance as per quality assurance oversight.

3. To Plan and co-ordinate vendor assessment and approvals for Raw Materials, critical consumables, Packaging Materials, testing animals and various service providers in coordination with Vendor management team and to maintain the record of the same.

4.To co-ordinate Unannounced as well as Announced audits in different departments like production, Quality Control Laboratory, Animal House, Warehouse, HRD, administratio,EOHS and Engineering department.

5. To check and verify the compliance of observations of Self-inspections.

6. To coordinate in the assessment/evaluation of contractual testing facilities/Service providers and to maintain the records of the same.

7.To prepare compliance of external audit observations and timely submission the compliance proofs to the respective regulatory authority.

8. Revision /Modification of concerned SOPs as and when required.

9. Participated in Media Simulation validation

10.Sound work on validation section.

11.Sound work on handling of Quality Management System.

12. Certified supportive internal auditor by PANERA Biotec.

13. Certified Trainer by PANERA Biotec

14. WHO-Geneva, NRA and CDSCO Audit faced

Job Responsibility in THEON PHARMA LTD.

1. Performing all IPQA checks in manufacturing area, and Packing area of dry powder injection.

2. Carrying out in process core sampling, finished product sample, quality control sample, validation sample and Stability sample.

3. Releasing finished product batch

4. Handling / assisting QMS elements during manufacturing to finished Product stages.

5. Participated in Media filling operation.

6. Dispensing of Raw Material and packing material in Warehouse

Job Responsibility in SKY MAP PHARMA

1. Performing all IPQA checks in manufacturing area, and Packing area of tablet, dry powder syrup and dry powder injection.

2. Giving line clearance before start of shop floor activities like dispensing, granulation compression, coating, Dry powder injection vial washing area, blending, filling and sealing of vials and packing operation.

3. Carrying out in process checks as per standard operating procedure/Batch record during manufacturing & packing operation of Tablet, Dry syrup and Dry powder injection.

4. Carrying out in process core sampling, finished product sample, control sample, validation sample and Stability sample.

5. Monitoring on line documents and making noncompliance observation

6. Handling / assisting in process unplanned deviation during manufacturing to finished Product stages.

7. Implementation of all norms of GMP and cGMP for shop floor.

8. Reviewing of BMR/BPR before batch dispatch.

9. Preparation Issuance, Receiving and Retrieval of Documents i.e. BMR, BPR, Written procedures, Records etc.

10. Stereo issuing

11. FGTN signing after completion of batch record and release of batch.

Educational Qualification.

Qualification

Institution

University/ board

Year

Division

B. Pharmacy

Sanjay College Of Pharmacy, Mathura

Gautam Budh Technical University, Lucknow.

2011

Ist

10+2

B.L.J. Inter College, Mirzapur. (U.P.)

U.P. Board Allahabad.

2006

IInd

10th

Pt.G.R.I.C.Mirzapur.

U.P. Board Allahabad .

2004

1st

Certification.

Clinical SAS programing from ICRI,New Delhi

Basic Computer Certificate

Registered Pharmacist from UPPC,Lucknow.

Training Program

* 60 days Industrial Training in Pill Pharma. Pvt. Ltd. Haridwar.

* Having training experience on SAS program from ICRI,NEW DELHI .

Summary of Skill

* Good time management and organizational skills

* Excellent command over written and verbal communication

* Good convincing and negotiation skill

* Familiar with major computer applications like MS Word, PowerPoint, Excel

and the Internet.

* Flexibility, result-oriented with good research and analytical skills.

* Good leadership

* Straight nature

Personal Details

Name : KAUSHIK GUPTA

Date of Birth : 18th jul, 1989.

Father s Name : Shri. Goverdhan Gupta

Marital Status : Single.

Gender : Male.

Nationality : Indian.

Language Known : Hindi & English.

Hometown Address : Rehara Chungi, Vindhyachal, Mirzapur (U.P.)

Pin Code : 231307

Declareation

I hereby declare that all are above information is true and correct to the best of my knowledge and belief.

DATE :

PLACE :

(KAUSHIK GUPTA)



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