Bhavin Solanki
Quality Specialist at Kedrion Biopharma- Claim this Profile
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Bio
Credentials
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FDA Inspection Readiness Certification
CfPA - The Center for Professional Advancement -
CAPA: Definition, Plan and Program
CfPA - The Center for Professional Advancement -
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
CfPA - The Center for Professional Advancement -
Conducting Successful Quality Audits
CfPA - The Center for Professional Advancement -
Data Integrity
CfPA - The Center for Professional Advancement -
FDA Case Scenarios: Best Practices for Managing Inspection Situations
CfPA - The Center for Professional Advancement -
Managing Effective Regulatory Inspections and 483 Responses
CfPA - The Center for Professional Advancement -
Applying Quality Risk Management
CfPA - The Center for Professional Advancement -
Best Practices for Investigation Deviations and Non-Conformances
CfPA - The Center for Professional Advancement -
Complaint Handling Requirements (US)
CfPA - The Center for Professional Advancement -
Implementing a Change Control Quality System Successfully
CfPA - The Center for Professional Advancement
Experience
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Kedrion Biopharma
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Specialist
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ene. de 2020 - - actualidad
Responsible for auditing of suppliers, internal auditing and managing quality agreement for suppliers. Tracking supplier quality and performing risk assessment. Compiling annual product review. Managing quality systems using Trackwise for change controls, deviation and CAPAs. Responsible for auditing of suppliers, internal auditing and managing quality agreement for suppliers. Tracking supplier quality and performing risk assessment. Compiling annual product review. Managing quality systems using Trackwise for change controls, deviation and CAPAs.
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Cipla
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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QA Assistant Manager
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ene. de 2019 - dic. de 2019
Reviewed Investigation reports, CAPA's, Process Validation Reports, APQRs. Coordinated equipment and facility qualification activities with engineering and maintenance department. Executed validation protocols on all major solid dosage form equipment: sifter, comminuting mills, double cone blender, PIAB, PTS, solution tank, compression machine, encapsulation machine, coating pan. Prepared Cleaning validation Matrix and sample location of equipment for cleaning validation. Write, review and revise SOPs as directed by QA Manager
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QA Associate
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jul. de 2016 - dic. de 2018
Reviewed Manufacturing Batch Records, Logbooks, change controls, Investigation reports, Process Validation Reports and Calibration Reports. Performed in-process activities and sampling at various stage during execution of Commercial, R&D and ANDA and validation batch records. Performed in process testing such as blend uniformity test, hardness, thickness, weight variation, disintegration, friability and AQL. Reviewed temperature and humidity data calibration, work request, PMP data and pest control records. Reviewed and executed Installation, Operational and Performance Qualification on major commercial equipment.
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QA
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ago. de 2010 - jun. de 2016
Reviewed Master Manufacturing Record ,Master Packaging Record and Laboratory analytical logbooks, deviation and CAPAs. Initiated and reviewed change control and out of specification. Performed internal audit in manufacturing area and warehouse. Assisted in Qualification and performing IQ/OQ/PQ of manufacturing equipment. Reviewed stability batches, validation reports and APQR. Reviewed of Allergen Forms and Specifications and raw material COA. Executed disposition of raw material and finished product with outside contractor. Reviewed COA for finished product and responsible for final release for finished product.
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Education
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2008 - 2009
Stevens Institute of Technology
Master of Science (M.S.), Pharmaceutical manufacturing -
2003 - 2007
A. R. COLLEGE OF PHARMACY & G.H.P. INSTITUTE OF PHARMACY(Diploma), V.V.NAGAR 401
Bachelor of Pharmacy (B.Pharm.)
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