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CURRENT PROFILE
Presently associated with Freseneius Kabi Pune as Assistant Manager in Quality Assurance Department,
since June ’2016.
CAREER ABRIDGEMENT
PROFICIENCY FORTE
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:
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:
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:
IPQA Activities:
INDUSTRIAL TRAINING
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
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:
I hereby declare that information given above is true to the best of my knowledge
and belief.
Date:
Place: Pune Dilip Singh Rajput