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CURRICULAM VITTAE

Dilip Singh Rajput


E-mail: dilipsinghrajput123@gmail.com,
Mobile: +919669656601

CURRENT PROFILE

Presently associated with Freseneius Kabi Pune as Assistant Manager in Quality Assurance Department,
since June ’2016.

CAREER ABRIDGEMENT

 Bachelor in Pharmacy with 8+ years of experience in Quality Management system,


Validation, and IPQA activities Exposure in Tablet, Effervescent Tablets, Capsules &
Pellets and sachet manufacturing and sterile formulations.
 A self –motivated team player with excellent communication, good presentation,
analytical, management and problem solving skills with Pleasing Personality.
 Team player capability to innovate and excel; to prove as asset for organization.

PROFICIENCY FORTE

 Quality Management System:


 Identifying, handling and execution of change control,
Quality Management Deviation and APQR
System  Partake in controlling, implementing, executing the activities of
Quality Assurance.
 To issuing of BMR/BPR to Production & maintain the BMR/BPR
issuance in Production System.
 Validation:
Validation  Preparation of protocols for carrying out validation at various
stages of manufacturing for regulated market and rest of
world.
 To carry out sampling for validation batches with respect to
the related documents like protocols etc. And compiling of
IPQA Activities validation reports.
 IPQA Activities:
 To check standard Operating Procedures Compliance and
execution at shop floor.
 To ensure that the batch is released after the compliance with
the specifications, after review of the batch processing records
and analytical results.

ORGANISATIONAL SCAN
Freseneius Kabi, Germany

Freseneius Kabi is one of largest Pharmaceutical industry in Drug formulation. it has above
100 manufacturing plant that exceed world’s standards and produce over 1000 products that
cater to just about every illness, approved by WHO, TGA, EU GMP, and other regulatory
bodies.
 Quality Management System:

 Identifying, handling and execution of change control and Deviation through Trackwise software.
 Investigation of customer complaint as well as implementation of the suggested corrective and preventive
actions.
 Issuance and control of BMR/BPR/SOP/monthly records/deviation/change control.
 To make Annual Product Review Reports.
 Organizing training, schedules for training for every department, competency matrix of individual staff and
questionnaire related to SOP`s for evaluation of training.
 Preparation of organization charts of the organization.
 Identification and finalization of job responsibilities of senior staff and individual staff of QA
 Preparing Quality Management Review Reports.
 To carry out Self inspections activities as self-inspection reports, compilations of observations and trending of
self-inspection observations.
 Partake in controlling, implementing, executing the activities of Quality Assurance.
 To issuing of BMR/BPR to Production & maintain the BMR/BPR issuance in Production System.
 To review the Batch Manufacturing records and batch packing records to ensure compliance to Standards.
 Preparation of Self-inspection schedule,
 Perform Self-inspection as per six system approach of cGMP.
 Preparation of Self-inspection Report & Compliance,
 Training, Evaluation and Certification of inspectors.
 Preparation and Review of Draft Compliance Report.
 Initiation and monitoring of CAPA associated with Self-Inspection and Regulatory Inspection Non-compliance.
 Experienced in working with the Compliance Manager for monitoring and review of compliance activities to
ensure that each and every individual activity is being complied with throughout the organization.
 Compliance to regulatory audits of plant.

 Validation:

 Preparation of protocols for carrying out validation at various stages of manufacturing for regulated market
and rest of world.
 To carry out sampling for validation batches with respect to the related documents like protocols etc. and
compiling of validation reports.
 To carry out sample management and check on line maintenance of documents.

 Monitoring of IPQA Activities:

 To establish and maintain a satisfactory system of Quality Assurance at shop floor.


 To check standard Operating Procedures Compliance and execution at shop floor.
 To ensure that the batch is released after the compliance with the specifications, after the review of the batch
processing records and analytical results.

ORGANISATIONAL SCAN
Cipla Pharmaceutical Limited, Indore SEZ

Cipla is A India’s number one largest Pharmaceutical industry in Drug formulation. Since
Jan’2009 it has 34 manufacturing plant that exceed world’s standards and produce over
1,200 products that cater to just about every illness, approved by USFDA, MHRA, WHO-
Geneva, MCC, TGA, ANVISA, Uganda, and other regulatory bodies.
 Quality Management System:

 Identifying, handling and execution of change control and Deviation,.


 To aid in the investigation of customer complaint as well as implementation of the suggested corrective and
preventive actions.
 To issuance and control of BMR/BPR/SOP/monthly records/deviation/change control.
 To make Annual Product Review Reports.
 Organizing training, schedules for training for every department, competency matrix of individual staff and
questionnaire related to SOP`s for evaluation of training.
 Preparation of organization charts of the organization.
 Preparing job responsibilities of senior staff and individual staff of QA
 Preparing Quality Management Review Reports.
 To carry out Self inspections activities as self inspection reports, compilations of observations and trending of
self inspection observations.
 Partake in controlling, implementing, executing the activities of Quality Assurance.
 To issuing of BMR/BPR to Production & maintain the BMR/BPR issuance in Production System.
 To review the Batch Manufacturing records and batch packing records to ensure compliance to Standards.

 Audit & Compliance / Self-Inspection


 Preparation of Self-inspection schedule,
 Perform Self-inspection as per six system approach of cGMP.
 Preparation of Self-inspection Report & Compliance,
 Training, Evaluation and Certification of inspectors.
 Preparation and Review of Draft Compliance Report.
 Initiation and monitoring of CAPA associated with Self-Inspection and Regulatory Inspection Non-compliance.
 Experienced in working with the Compliance Manager for monitoring and review of compliance activities to
ensure that each and every individual activity is being complied with throughout the organization.

 SAP
 SAP Implementation: Involved in QM related master data preparation, SAP SOP/Manuals training &
implementation, Data Mapping, Conversion & migration from legacy to SAP, Role and Authorization
management, Unit level implementation of SAP.

 Validation:

 Preparation of protocols for carrying out validation at various stages of manufacturing for regulated market
and rest of world.
 To carry out sampling for validation batches with respect to the related documents like protocols etc. and
compiling of validation reports.
 To carry out sample management and check on line maintenance of documents.

 IPQA Activities:

 To carry out line clearance checks and in-process checks.


 To establish and maintain a satisfactory system of Quality Assurance at shop floor.
 To check standard Operating Procedures Compliance and execution at shop floor.
 To ensure that the batch is released after the compliance with the specifications, after the review of the batch
processing records and analytical results.
 Verification of online rejection and destruction if any.
 Cleanliness, environment monitoring and control and at the start and during every process in the production
area (manufacturing and packing).
USV Limited (Daman)

Quality Assurance Officer July’07 – December’08


USV leads the oral anti-diabetic market in India by Rx and by value. In the cardiovascular
disease segment it leads in terms of prescription generation. it has held these positions
consistently for almost 2 decades approved by WHO, ISO, USFDA, MCC, EU.

 IPQA Activities:

 To carry out line clearance checks and in-process checks.


 To establish and maintain a satisfactory system of Quality Assurance at shop floor.
 To check standard Operating Procedures Compliance and execution at shop floor.
 To ensure that the batch is released after the compliance with the specifications, after the review of the batch
processing records and analytical results.
 Verification of online rejection and destruction if any.
 Cleanliness, environment monitoring and control and at the start and during every process in the production
area (manufacturing and packing).

INDUSTRIAL TRAINING

 Jaywin remedies pvt. Ltd. Ahmadabad Gujarat.

ACADEMIC CREDENTIALS

2001 Passed High School with 58% from Vandana Convent School (CBSE ) , Guna (M.P).
2003 Passed Higher Secondary with 59.11% from Govt. School M.P. Board, Bhopal.
2007 Bachelor in Pharmacy with 67.44% from RGPV University Bhopal in year
2009 Master Of Business Administration In Production Management From Sigma Institute Of Management
Bhopal (M.P) Affiliated to Vinayka Mission University Tamil Nadu .

IT PROFICIENCIES

 MS-OFFICE/Windows 98/2000/2003/2007xp/2013 and Internet Surfing.


 Laboratory Information Management System and SAP and Production System of cipla Ltd.

PERSONAL PROFILE

 Brief profile - I am a person with great devotion for work and I am always
determinant to give the best efforts to bring out the desired results.
 Strengths - Determined, Assiduous, Adaptable.

 Hobbies & Interest - Playing cricket, Watching Discovery programmes, listening soft
music.
 Date of Birth – 22nd June 1985.
 Marital Status - Married
 Languages Known - English, Hindi, Marathi and Gujrati
CONTACT ADDRESS

Permanent Address: C- 27 ShivDham Colony, Khandwa road, Indore (M.P), Pin code -452017

References:

Mr. Ashish Patel Mr. Anil Rajani


Section Head Quality Assurance Dy. General Manager Packaging
Cipla Ltd. Indore Alembic Ltd. Baroda

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

Date:
Place: Pune Dilip Singh Rajput