Tushar Rajput
Indore
Summary
To build a long-term career in pharmaceutical industries with opportunities for career growth and to solve problems in a creative and effective manner in challenging position
Overview
18
18
years of professional experience
Work History
Deputy Manager – CQA
CIPLA LTD. Indore
Indore
11.2013 - Current
- Functional Leader: To lead the section of QMS review, SOP review and site training activity
- Deviation Handling: To review a deviation record and categorised deviation
- Evaluate immediate action and proposed CAPA
- Evaluate root cause analysis
- To evaluate impact on the other batches, product, system, material, document and facility
- Inform to customer about deviation as per respective technical agreement of customer
- To evaluate the repetitive nature of deviation based on deviation trends
- Review the audit trail and close out the deviation
- Investigation and root cause analysis: To conduct cross functional meeting for preliminary evaluation on non-conformance, impact assessment and propose immediate measures or remedial action based on preliminary evaluation
- To form the investigation team with cross functional member
- To investigate non-conformance and identify the root cause or most probable cause by using different tool of RCA
- To perform risk assessment based on outcomes of investigation
- To proposed CAPA based on Root Cause analysis
- Corrective and Preventive action: To log the child CAPA or Standalone CAPA based on root causes
- To assess the impact of CAPA
- To implement the CAPA and check the effectiveness of CAPA
- Review the audit trail and close out the CAPA
- Compliant Handling: Review compliant record and categorised the compliant
- To evaluate impact on the other batches and product
- Perform the investigation of complaints and proposed CAPA
- Inform to customer about compliant as per respective technical agreement of customer
- Close out the compliant and Trending of complaints
- Change Control and SOP Review: To evaluate the change control , implementation of proposed Change control and close out of change control after implementation
- To review and implement the Unit and Corporate SOP at site
- To track periodic review of SOP
- To perform the Unit Operation of SOP and identify the gap between written procedure and current practice
- Training Activity: To coordinate site training activity.
Sr. Officer Corporate Quality Assurance
INTAS PHARMACETICALS LTD. Ahmedabad
Ahmedabad
02.2008 - 11.2013
- To carry out Quality audit of all API, excipients and packing material supplier’s manufacturing facility and contact laboratories based on ICH Q7, USFDA and MHRA guidelines and to submit audit report
- To handle the loan license manufacturing activity and carry out quality audit of all LL finished product manufacturing site
- To release and inspect the all LL manufactured product the batches
- Evaluation of compliance report received from vendor and subsequent co-ordination with vendor for audit compliance
- To co-ordinate with vendor and LL manufacturer for the compliance of complaints and recommends actions to continually improve the quality
- To prepare and maintain Technical Agreements between Intas and Vendor considering Regulatory Requirements
- To perform various vendor qualification activity in SAP.
Chemist Quality Assurance
ARISTO PHARMACEUTICALS PVT. LTD. Daman
Daman
03.2007 - 02.2008
- To perform IPQA activities like giving line clearance at various stages of manufacturing and packaging, perform inprocess test as per BMR at predefine time interval
- Review of manufacturing and packaging records and their subsequent analytical report
- To perform manufacturing process validation as per approved validation protocol.
Chemist Quality Assurance
BIOCHEM PHARMACEUTICALS INDUSTRIES Daman
Daman
07.2006 - 03.2007
- To perform IPQA activities like giving line clearance at various stages of manufacturing and packaging, perform inprocess test as per BMR at predefine time interval
- Review of manufacturing and packaging records and their subsequent analytical report.
Education
Master of Science in Organic Chemistry -
NORTH MAHARASHTRA UNIVERSITY
Skills
- QMS review
- SOP review
- Site training activity
- Deviation handling
- Categorizing deviation
- Immediate action evaluation
- CAPA proposal
- Root cause analysis evaluation
- Impact evaluation on batches, product, system, material, document, and facility
- Customer notification about deviation
- Deviation trend evaluation
- Audit trail review and closure
- Investigation and root cause analysis
- Cross-functional meeting for non-conformance evaluation
- Preliminary evaluation of impact assessment
- Immediate measures or remedial action proposal
- Investigation team formation
- Non-conformance investigation
- Root cause identification using RCA tools
- Risk assessment based on investigation outcomes
- CAPA proposal based on root cause analysis
- Child CAPA or Standalone CAPA logging
- CAPA impact assessment
- CAPA implementation and effectiveness check
- Complaint handling
- Categorizing complaints
- Impact evaluation on batches and product
- Complaint investigation and CAPA proposal
- Customer notification about complaint
- Complaint closure and trending
- Change control evaluation
- Proposed change control implementation and closure
- Unit and Corporate SOP review and implementation
- Periodic SOP review tracking
- Unit operation of SOP and gap identification
- Site training activity coordination
- Quality audit of API, excipients, and packing material supplier's manufacturing facility
- Quality audit of loan license finished product manufacturing site
- Release and inspection of loan license manufactured product batches
- Compliance report evaluation and coordination with vendors
- Compliance of complaints coordination with vendors and loan license manufacturers
- Technical Agreements preparation and maintenance
- Vendor qualification activity in SAP
- IPQA activities like line clearance and in-process testing
- Manufacturing and packaging records review
- Manufacturing process validation
- Trackwise for Deviation, CAPA, and Complaint
- SAP
- Documentum for Change Control and SOP
- LMS for training
Signatureanddate
_________________ (TUSHAR D. RAJPUT)
Phonenumbers
- 8462003440
- 7974533788
Personal Traits
- Honest
- Punctual and a man of strong integrity
- Smart working and positive attitude with assignment
- Ready to accept changes and challenges
- Believes in Knowledge sharing
- Ability to learn new skill very fast, quick learner and good observer
- Excellent team player
Personal Information
Marital Status: Married
Timeline
Deputy Manager – CQA
CIPLA LTD. Indore
11.2013 - Current
Sr. Officer Corporate Quality Assurance
INTAS PHARMACETICALS LTD. Ahmedabad
02.2008 - 11.2013
Chemist Quality Assurance
ARISTO PHARMACEUTICALS PVT. LTD. Daman
03.2007 - 02.2008
Chemist Quality Assurance
BIOCHEM PHARMACEUTICALS INDUSTRIES Daman
07.2006 - 03.2007
Master of Science in Organic Chemistry -
NORTH MAHARASHTRA UNIVERSITY
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