Dilip Kr. Sinha

Experience

• 

  Indian Institute of Technology, Delhi

  Sept 2003 - Aug 2004

  Research Scholar

  Antibiotics production and purification...down stream processing (Semi synthetic Penicillin)

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  Alkem Laboratories Ltd., Mumbai

  Sept 2004 - Aug 2008

  Main Responsibility:* Microorganisms development through fermentation (Liquid and solid state)..Bio-fermenter handle and interpretation of data. • Process design, Process development & Optimization of critical parameters.• Downstream processing of product includes Micro filtration, Ultra filtration, Nano Filtration, Centrifugation and other technique. * Food grade Enzymes production through microorganisms such as Alfa amylase, Lipase, Cellulase,...etc. • Product Technology Transfer from Laboratory scale to Production scale, Scale up study.• Project planning, coordination & implementation on the basis of engineering calculations. Show less

  • Sr. Research Scientist (Process Develop / Technology Transfer)

    Sept 2005 - Aug 2008

  • Research Executive - Biotechnology

    Sept 2004 - Aug 2005
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  Kopran Ltd

  Sept 2008 - Apr 2011

  Sr. Executive (Quality Assurance & Process Engineer),

  Main Responsibility:* Quality management system development, Assuring quality of products by• Ensuring SOP compliance.• Performing internal quality audits• Controlling the changes made to facility / equipment / product / process and master documents by following change control procedure.• Ensuring implementation of Corrective actions/Preventive actions proposed in Deviation/Failure investigations and Customer complaints. Validation:• Prepare and Review of validation plans for facility / equipments / process including cleaning. • Review of protocols for qualification and validation of facility / equipment / product / process. • Review of validation reports after execution of validation of facility / equipment / process.Others:• Review and control of Specifications, STPs.• Review of method transfer protocols and responsible for executing the same.• Co-ordination of stability studies as per ICH guidelines. Show less

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  Arnold A Semler Inc. DBA Associated Industries

  Apr 2011 - Mar 2012

  Asst. Manager, GxP (Quality assurance, Validation and Project)

  Worked with Semler Research Center (SRC) which is part of US based Arnold A Semler Inc, in business since 1946. SRC, founded in 2006, is a privately owned pharmaceutical services company with its business offices in Los Angeles, CA and Bangalore, India. India's first independent organization to fully integrate drug development, clinical development and manufacturing services. In addition SRC managing a team of highly qualified GxP consultants placed in pharmaceutical manufacturing units across Asia, Africa and Europe to support quality systems, GxP compliance and regulatory audits.  Implementation and maintenance of Quality Management System in entire plant with the current regulatory requirements. Performing the gap analysis of current and revised regulatory requirements. Reviewing all the validation / qualification documentation and activities throughout of plant.  Inspection of various Process Equipment's, Utilities services at supplier site (FAT audit) for new projects.  Assessing Quality Risk / Handling Trouble Shooting using Quality tools. GMP inspection compliance and CAPA preparation and submission to applicable regulatory agencies such as UK-MHRA, TGA-Australia & US-FDA. Show less

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  Adcock Ingram

  Apr 2011 - Mar 2012

  Associate Manager, GxP (Quality Assurance, Validation)

  Adcock Ingram is a leading South African pharmaceutical company with a proud 120 year heritage. It hasa portfolio of trusted, quality brands and generics and an entrenched value system that assures integrity Growing from humble beginnings as a small Krugersdorp pharmacy in 1890, Adcock’s portfolio now includes an extensive range of prescription and over-the-counter (OTC) products and life saving hospital prodcuts. Adcock Ingram has expanded into key African markets over the past few years with infrastructure in Kenya, Ghana and export sales in most Sub saharan territories.Main Responsibility:  Support Quality system development, GxP compliance and regulatory audits.Implementation and maintenance of Quality Management System in entire plant with the current regulatory requirements. Performing the gap analysis of current and revised regulatory requirements. Reviewing all the validation / qualification documentation and activities throughout of plant.  Inspection of various Process Equipment's, Utilities services at supplier site (FAT audit) for new projects.  Assessing Quality Risk / Handling Troubleshooting using Quality tools. GMP inspection compliance and CAPA preparation and submission to applicable regulatory agencies such as UK-MHRA, TGA-Australia & US-FDA.Quality Management system development (Handling Deviation / Change control / CAPA / Risk Assessment), Process validation, Processing Equipment qualification. Facility & System Validation/Qualification, Utilities Validation (Purified water, HVAC system, Compressed Air, Nitrogen system). Supplier qualification. Project Management. Show less

• 

  Reckitt Benckiser

  Apr 2012 - Apr 2014

  RB is the world's leading consumer healthcare and Pharmaceutical company, with brands (such as Disprin, D'Cold, Nurofen, Strepsils, Mucinex, Dettol, Lysol Finish and Vanish) sold in nearly 200 countries and operations in over 60 countries. Every day, we strive to find even better ways to give people innovative solutions for healthier lives and happier homes. Feeling well is at the heart of RB's rapidly growing consumer health business. Making a difference to the lives of consumers means we continually invest in research and innovation to stay ahead of the game. In fact, we are changing the game in consumer health. Ranked in the TOP 20 on the London Stock Exchange, our relentless drive to outperform has trebled our revenue since 2000 and quadrupled our market cap.Main Responsibility:• Providing technical support to manufacturing site while implementation of Quality management systems to fulfill the regulatory norms. Ensuring Implementation of CAPA proposed in Deviation, Change control, Failure investigation and Customer complaints.• Review of all GMP documents/activities for Project & Plants such as: Deviation, Change control, Risk Management (HACCP, FMEA), Process validation protocol & Report, Method validation, Equipment/System qualification protocol & Report, Exhibit and executed BMR, BPR.• Project Planning and Scheduling of Validation and Qualification activities of System/Process, Cleaning and Equipments. Prepare & Review of all qualification document (URS, DQ, IQ, OQ and PQ) as per cGMP norms. Show less Main Responsibility:• Providing technical support to manufacturing site while implementation of Quality management systems to fulfill the regulatory norms. Ensuring Implementation of CAPA proposed in Deviation, Change control, Failure investigation and Customer complaints.• Review of all GMP documents/activities for Project & Plants such as: Deviation, Change control, Risk Management (HACCP, FMEA), Process validation protocol & Report, Method validation, Equipment/System qualification protocol & Report, Exhibit and executed BMR, BPR.• Project Planning and Scheduling of Validation and Qualification activities of System/Process, Cleaning and Equipments. Prepare & Review of all qualification document (URS, DQ, IQ, OQ and PQ) as per cGMP norms.• Planning and execution validation of Purified water system, HVAC system, Compressed air system, Nitrogen system etc. • Supplier qualification of Processing and Engineering equipment (FAT/SAT audit). Responsible for supplier/vendor qualification program (Vendor audit, vendor rating & vendor assessment).• Responsible for Planning and execution of Facility validation, Utility validation, Area qualification, Equipment Qualification under cGMP norms.• Preparation, review and implementation of Standard Operating Procedure (SOP’s).• Responsible for internal audit & compliance of the quality system to meet the regulatory requirements. Performing internal audits & self inspections for effective Quality System in the facility and for further improvements in QMS. Show less

  • Manager GxP (Quality Assurance/Validation, Project QA)

    Oct 2013 - Apr 2014

  • Consultant, GxP (Quality assurance/Validation & Project QA)

    Apr 2012 - Mar 2014
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  Roquette Freres

  May 2014 - now

  About ROQUETTE "Offering the best of nature" French MNC. Roquette is a family owned global leader in plant based ingredients, a pioneer of plant proteins and a leading provider of Pharmaceutical excipients and life saving active ingredients for the pharmaceutical and biopharmaceutical industries.Founded in 1933, the company currently operates in more than 100 countries, has a turnover of 4 billion euros, and employ more than 8000 people worldwide.Main Responsibility:• Leading Third Party Operations Quality for APAC region. As a certified Lead auditor (IRCA), leading various Quality Audits of various formulations, APIs, Excipients manufacturers/suppliers, service providers, GDP, contract manufacturing sites and Roquette manufacturing sites.• Handling Supplier Management system. Responsible for Raw & Packaging material, Ingredients & Chemicals, Contract Laboratory Supplier/vendor qualification (Vendor audit, vendor rating & vendor assessment).* Provides leadership and ensures the success of external manufacturer qualification and monitoring, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability. Provides balanced management of quality and compliance risks with business needs.• Performing internal audits & self inspections for effective Quality System & Regulatory compliance in the facility and for further improvements in QMS.* Investigation and handling of Market complaint for imported products. • Toller manufacturing and 3rd Party contract mfg supplier audit and assessment. Monitor the effectiveness of QA system including training people.• Assuring quality of products by ensuring SOP compliance & On-site assessment of vendor. Show less Main Responsibility:* Implementation and maintenance of Quality Management System in entire plant with the GMP and current regulatory requirements.• Performing the Gap analysis of current and revised regulatory requirements.• To monitor Change controls, Planned & unplanned deviations, Corrective and preventive actions (CAPA), Risk Analysis associated with product/process & compliances.• Investigation and handling of Market complaints & product recall system. Ensuring implementation of CAPA proposed in Deviation, Change control, Failure investigation.• Review of all GMP documents/activities for Project & Plants such as: Deviation, Change control, Risk Management (HACCP, FMEA). Monitor the effectiveness of QA system including training people.• Responsible for internal audit & compliance of the quality system to meet the regulatory requirements. Performing internal audits & self inspections for effective Quality System in the facility and for further improvements in QMS. Show less

  • Regional SQA Manager - Greater Asia

    Aug 2018 - now

  • Quality Assurance Manager

    May 2014 - Jul 2018