Cv for the Post of Manager QA/ Deputy Manager QA
Resume:
CURRICULUM VITAE
KRISHAN KR. DINDHORIA
PRESENT ADDRESS:
Hotel Comfort Home
Room No.:-413
Udham Singh Nagar
RudraPur Distt-U.S.Nagar
Uttrakhand, INDIA
Mobile: 082********
099******** (Faridabad Contact No.)
Email: ***************@*****.***
*************@*****.***
CAREER AIM
To be there where I can exaggerate my knowledge and explore my skills to become a part of today’s technology.
PROFILE SUMMERY
A Quality Assurance and Regulatory professional with experience more than 8+ years in the good pharmaceuticals industries both in factory and corporate level. Proven leadership skills involving managing, developing and motivating teams to achieve their objectives. Dedicated to maintaining high quality standards. Able to work on own initiative and as part of a team.
Endeavor
To become a distinguish professional in the area of Quality Assurance.
Personal Aptitude
Discipline, Sincerity & performance are the essence to my existence.
VALUES
Commitment, Dedication, Discipline, Self confident, Hard working, punctual, positive attitude and very honest towards my work.
EDUCATIONAL QUALIFICATIONS
EXAM PASSED
PASSED OUT BOARD/UNIVERSITY DIVISION
M.Sc. (Biotech.) 2004 Barkatullah University, Bhopal Ist Div.
B.Sc. (Medical) 2002 MD University, Rohtak IInd Div.
10th+2 (Medical) 1999 H.B.S.E Board llnd Div.
Matriculation 1995 H.B.S.E Board IInd Div.
CARRIER ACHIEVEMENTS
About eight years plus work experience in Quality Assurance both in factory and corporate level.
Lead the QA team for Successful Certification for UKRAINE, W.H.O.
Developed a proactive IPQA team to counter act the day-to-day problems.
Solved major quality assurance problems, which temporarily halted in production, with support from department heads.
CURRENT APPOINTMENT : 26th NOV. 2012 to till date.
Designation : Deputy Manager Q.A.
Current Company : BAL PHARMA LIMITED
Company Profile: The Bal Pharma Limited is located at SIDCUL Industrial Area Pantnagar, Rudrapur (Uttarakhand) and it is certified by ISO-9001, WHO-GMP, company deals in Tablets, Capsules External Preparations & having very strong performance in international and domestic market.
Present job profile:
1) Preparation and review of all Departments Standard operating procedures (SOP’s) for cGMP compliance. Implementation of cGMP practices in the facility.
2) Preparation and update the Site Master File.
3) Preparation of Annual Product Reports.
4) Investigation of root causes and implementation of corrective and preventive actions.
5) Handling of Deviations, Non-conformances, Out of Specification, Change Controls and CAPA Tracking.
6) Preparation of Training syllabus, Training needs, Training modules & training calendars. Imparting training on shop floor.
7) Review Master BMR’s and BPR’s. Responsible for In-process of products.
8) Responsible for Calibration of IPQA instruments.
9) Preparation of IQ, OQ, PQ of Equipments.
10) Validation activities. HVAC validation, Cleaning Validation, Process validation and also
preparation of all type of qualification documents.
11) Co-ordination with Validation team to perform validations.
12) Assuring seniors in conducting Self-inspection/internal Audits at plants.
13) Attended few important trainings conducted by external party regarding cGMP.
14) Coordinating with rest of departments for smooth functioning.
15) Knowledge of Temperature Mapping and done by External.
16) Training to Fresher’s & New Joining. Trainings to the Production Executives and
Operators whenever required.
17) Preparation and execution of Shift Schedules of IPQA team month wise.
18) Submission of Application regarding COPP, FSC and Product License to Drug Office,
Dehradun.
19) Coordination with other departments Production, Ware House, QC, Micro and
Engineering & Utility for smooth functioning.
AUDIT EXPOSURE
1. WHO-GMP
2. GMP-KENYA
3. EU-GMP
4. GMP-COMBODIA
5. GMP-NEPAL
6. US-FDA (TRIGEN)
7. UKRAINE AUDIT
Details of Experience
1) Experience as an Assistant Quality Assurance Chemist with Brawn Laboratories Limited. N.I.T. Faridabad (An ISO 9001-2000 WHO, GMP Certified) since 7th Sep. 2004 to 18th Oct. 2005.
Company Profile: - Brawn Laboratories Limited is a WHO GMP and 9001-2000 certified company with annual turnover of 100 crore with a strong performance in domestic and international market manufacturing wide range of pharmaceutical product like Tablets, Capsules, Syrups, Cream, Ointments and parental.
2) Experience as a Q.A. Executive with Synmedic Laboratories Sec-31 HSIDC Faridabad. (An ISO 9001-2000 WHO Certified Pharmaceutical Company) since 10th Nov. 2005 to 21st Sep.2008.
Company Profile: - Synmedic Laboratories is a WHO, GMP and ISO Certified
Company with annual turnover of 100 crore with a strong performance in the International Market and CIS countries. The company has the approx. 10% domestic Market also and ready for enter the US and Europe Market.
3) Experience as a Sr. Executive Q.A. with Gracure Pharmaceuticals Ltd. Bhiwadi. (An ISO 9001-2000, WHO & EU-GMP Certified company) since 25th Sept. 2008 to 03rd Sept. 2010.
Company Profile: - Gracure Pharmaceuticals Limited is an ISO, WHO, GMP and EU-GMP Certified Company with annual turnover of 100 crore with a strong performance in the International Market of Russia and CIS countries. The company has the approx. 5% domestic Market.
4) Experience as an Assistant Manager Q.A with Lark Laboratories (I) Limited. Bhiwadi (Rajasthan) (An ISO 9001-2000, WHO-GMP Certified) since 25th Nov. 2010 to 24th Nov. 2012.
Company Profile: - Lark Laboratories (I) Limited is a WHO-GMP and 9001-2000 certified company with annual turnover of 100 crore with a strong performance in domestic and international market manufacturing wide range of pharmaceutical product like Tablets, Capsules, Liquid Oral & External Preparation.
AREAS OF EXPOSURE
Knowledge of all Quality Assurance related activities and internal audits.
Qualification of equipments, Validation & all related documents.
Knowledge of In-process work of all sections like Tablet, Capsule, Dry syrup, Liquid, Cream, Ointment & Parental section.
Flair knowledge of Regulatory work.
Regulatory work like COPP for new products and submission of dossiers.
Knowledge of Dry Injectable also.
TRAINING UNDERGONE
• “ONLINE DOCUMENTATION” Conducted by Jimmy Karihalu
• cGMP & EU-GMP Training conducted by S.W. Kolhatkar.
• Qualification & Validation by Gery Demarteau.
• Market & Product recall by Gery Demarteau.
• Risk Assessment by Gery Gemarteau.
• “HACCP” Training conducted by S.W. Kolhatkar
• Many more conducted in house.
INTEREST
My interest is to continuously work on my general awareness. I do this by watching informative programs and reading books.
PERSONAL PROFILE
Name : Krishan Kumar Dindhoria.
Father’s name : Sh.Hari Singh Dindhoria.
Mother’s name : Smt. Geeta Devi.
Date of birth : 3rd November 1978.
Nationality : Indian.
Marital Status : Married.
Languages Known : English, Hindi, Punjabi & Haryanvi.
Permanent address : House No. 1639 Sec-23/A
Housing Board Colony
N.I.T. Faridabad, (HARYANA)
PIN-121005
Salary Drawn : Rs. 5.0 Lac Per Annum
Krishan Kumar Dindhoria Place
Deputy Manager Q.A. Date
Bal Pharma Limited
Plot No.: 1, 2, 3 & 69, Sector-4,-IIE
SIDCUL,Pantnagar,Rudrapur
Distt. Udham Singh Nagar
(Uttarakhand). Pin-263153
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