1. Rajesh kumar khandelwal
Current location: Bhiwari Alwar
From:Rajasthan
Mobile: 09592889055
08769442138
E-mail: rajeshgupta14@gmail.com
Objective
I would like to continue my professional career in the pharmaceuticals by working with a reputed
organization like yours by using the skills and knowledge those I have attained throughout my
experience in my current as well as previous companies.
I am having more than 7 years of experience in Pharmaceutical QA in highly regulated and disciplined
environment like MHRA, TGA, ANVISA UGANDA, GCC,UKARAIN, EU GMP etc. and developed
myself as a very disciplined and organised Quality professional.
Work Experience (7.5 Years)
Gracure Pharmaceutical limited Sr.Executive-QA Bhiwari,Rajasthan
Current-Jan2014 to Till Date
I am currently working in one of the pharma company situated in the north India and performing
following responsibilities as a member of quality team;
1. To handle deviation raised by different departments from review to closing including follow up
with department heads.
2. To prepare schedule for self inspection (Internal audit) of various departments and also take part
in them with quality head.
3. To take part in Investigations for any non-compliances and also suggest appropriate CAPA with
co-ordination of department head.
4. To face the regulatory audits and customer audits and also actively participate in preparing the
audit compliance and implementation of updated system.
5. An important team member in implementing and tracking of CAPA for all the quality aspects like
deviation, Non-conformity etc.
6. Involved in review of Batch manufacturing record and Batch manufacturing before batch release
and also sort the issue out before batch release.
7. To review the validation and qualification documents as a preparation of the audit.
8. Involved in handling Change control including impact analysis and closing them after considering
all the aspects after completion of all the required actions.
9. To support manufacturing & packaging operations as a quality person & also to guide IPQC
officers for any query or non-conformity.
10. To participate the OOS and OOT investigation.
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2. Ind- Swift Ltd. Sr. Officer - QA Chandigarh, Punjab
(From Jan. 2010 to Jan 2014)
1. To handle deviation raised by different departments from review to closing including follow up
with department heads.
2. To prepare schedule for self inspection (Internal audit) of various departments and also take part
in them with quality head.
3. To take part in Investigations for any non-compliances and also suggest appropriate CAPA with
co-ordination of department head.
4. To face the regulatory audits and customer audits and also actively participate in preparing the
audit compliance and implementation of updated system.
5. An important team member in implementing and tracking of CAPA for all the quality aspects like
deviation, Non-conformity etc.
6. Involved in review of Batch manufacturing record and Batch manufacturing before batch release
and also sort the issue out before batch release.
7. To review the validation and qualification documents as a preparation of the audit.
8. Involved in handling Change control including impact analysis and closing them after considering
all the aspects after completion of all the required actions.
9. To support manufacturing & packaging operations as a quality person & also to guide IPQC
officers for any query or non-conformity.
10. To participate the Hvac validation and compressed air validation activity.
Ankur drugs pharma Ltd. QA - Officer Baddi, HP
(May 2008 to Dec.2009)
1. To take part in validation activities for manufacturing and packing areas including process and
equipment.
2. To handle Change control and Deviation activities mainly with respect to production and review
the same.
3. To ensure the timely calibration of the instruments in Quality control and prepare the schedule for
the same.
4. Monitoring & control shop floor activities.
5. Implementation of QA system at shop Floor & follow up of the cGMP.
6. To give Line Clearance at each and every stage as required, to check all records e.g. BMR/BPR,
Log books regularly.
7. To carry out In-Process checks & sampling in section of Tablets, Capsules, Oral liquid and Dry
syrup of Cephalosporin and Beta lactum block
8. Coordinate and follow up the release status of products from QC Department.
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3. Biogenetic Drugs Pvt. Ltd QA - Officer Baddi, HP
(Aug. 2007 to Apr. 2008)
1. IPQC Checks like Line Clearance, Sampling and process monitoring, BMR & BPR Review,
Reconciliation, and Yield Calculation in tablets & Capsules.
2. Take part in Change controls and Deviation activities mainly with respect to production and
review the same.
3. To take part in validation activities for manufacturing and packing areas including process and
equipments.
4. To review executed BMR, BPR & analytical documents before batch release.
5. Arrange routine meetings with production heads and discuss on quality and safety issues.
6. Preparation of Annual Product Review (APR) including trend analysis and summary.
7. To ensure cGMP compliance at all levels of activities.
Qualifications
Bachelor of Pharmacy: July 2002 to June 2007 (First class)
Rajasthan University of health science,Jaipur
Key modules:
•Pharmaceutical instrumentations and handling,
•Pharmacognocy
•Pharmaceutical Dosage forms
•Industrial Pharmacy
•Dispensing pharmacy
•Pharmacology and Drug effects
•Drug discovery and development
Key technical skills
•Excellent ability to manage a team of people and also able to maintain and even improve the quality
systems of the company with novel better ideas if required.
•Even under significant pressure, possesses a strong ability to perform effectively.
•Good knowledge of MS-Office (Word, Excel, Power-Point, outlook, Access) Internet, Email etc.
•Have an ability to work for long time with the same concentration, accuracy and patience.
Personal details
Health : Excellent; Non-Allergic
DOB : 14Aug. 1980
Marital status : Married
Languages : English,Hindi,
Interests and activities
•To involve in religious activities and meditation.
•Pharmaceutical is my passion and like to join in the environment of such professions and also like to
take training of any different Quality system.
•In leisure time, preferred to go to sports centre for improving health and for enjoyment.
•Like to play & watch Cricket.
References
References will be provided up on request.
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