RAMPRASAD M

To achieve challenging and responsible position in the area of Pharmaceutical Quality Assurance and Regulatory affairs in Bio-Pharmaceutical Industry that fosters creativity and innovation through trust, flexibility and freedom to work towards organizational goals for a Quality Product and benefits coupled with career orientations.

17 years of experience in Quality assurance (Handling of QMS and IPQA activities).

Quality Professional

• Biocon Sdn Bhd, Manager, Quality Assurance, Participating in the investigations, review and approval of Product failure investigations (OOS & OOT’s)., Participating in the investigations, review and approval of deviations with respect to manufacturing process, facility and Utilities., Review, evaluation and approval of Change controls with respect to Process, facility and Standard operating procedures., Review of CAPA proposed based on the outcome of the investigations. Evaluating the requirement of CAPA effectiveness monitoring. Evaluation and approval of CAPA effectiveness monitoring., Monitoring regular IPQA activities., Monitoring APS(media fill activities) as per the planner., Evaluating the intervention trending as per the schedule., Handling of Monthly Management reviews., Preparation, review and approval of Standard operating procedures., Playing a pivotal role in regulatory and customer audits with respect to QMS elements and Manufacturing assurance., Review of Annual Product Quality Review reports., Review and approval of risk assessment reports., Review and approval of study protocols and reports, Handling of Customer complaints, Handling of batch release activities., Review and approval of e-BMR., 11/2016, 06/2022
• Dr. Reddy’s Laboratories, Assistant Manager, Engineering Assurance, Involving in monitoring of Equipment instrument qualifications and approval of the same., Involving in Periodic monitoring of facility (clean room:- ISO Class8) qualifications and approval of the same., Involving in regular monitoring of water systems (Potable & Purified water system and monitoring water trends., Handling of investigations related to water system failures., Involving in regular monitoring of the utility systems such as Nitrogen and compressed air generation system., Involving in the execution of new facility commissioning and qualifications, Played major role in implementation of simplification activities with respect to Engineering qualifications and reduction of regular environmental monitoring samples in the clean room., Involved in the implementation of automation projects such as establishing data logging systems., Conducting vendor audits with respect to the Engineering services., Handling of Product failure investigations (OOS & OOT’s)., Handling of Change controls., Preparation, review and approval of Standard operating procedures., Playing a supporting role in regulatory and customer audits., Preparation & Review of Annual Review reports., Review of risk assessment reports., 01/2012, 11/2016
• Biocon Ltd, Senior Executive, Quality Assurance, Handled Process validations and cleaning validations., Preparation of Process validation & Cleaning Validation Protocols and reports., Preparation of Annual Product reviews., Handling of Customer complaints., Answering of Customer Questionnaires., Review of Batch manufacturing records & Packing and Dispatch records., Monitoring of regular dispatch activities., Monitoring of cGMP activities., Preparation & Review of Standard Operating procedures., Playing a pivotal role during Regulatory and Customer audits., Review of Microbiology Protocols pertaining to Environmental Monitoring and Water systems., Conducting regular cGMP inspections., Review of Technology Transfer documents., Review of Change Controls., Review of Deviations (Planned & Unplanned)., Issue of Line Clearance., Preparation of Temperature validation protocols for Temperature sensitive products., 12/2006, 01/2012

• Stelis Biophama: Biologics DS: Premolizumab (Development Stage)
• Biocon Limited: Category of Products: 1) Biologics Recombinant / biological products (Recombinant Human Insulin, Insulin Glargine, Insulin Aspart, Recombinant Human Granulocyte Colony Stimulating Factor, Recombimnant Streptokinase, BVX-20). 2) Synthetic API Synthetic Products –Statins (Simvastatin, Atorvastatin, Pravastatin & Fluvastatin) Anti Diabetic (Repaglinide)
• Products handled at Dr. Reddy’s Laboratories: Synthetic API’s: Ramipril Omeprazole Magnesium Esomeprazole Magnesium Pantoprazole Sodium Rabeprazole Sodium Amlodepine Besilated and Amlidipine maleate Levocitrizine di HCl Aprepitant Zoledronic acid Alendronate sodium Palanosetron

• USFDA in Aug-2022 facility audit
• US FDA in Feb-2020 for Insulin Glargine
• EMA audit in May-2019 for Insulin Glargine
• Health CANDA OSE in September- 2018 for Insulin Glargine
• USFDA audit in April-2018 for Insulin Glargine
• ANVISA audit in July-2017 for Human Insulin
• EMA audit in April-2017 for Insulin Glargine
• USFDA audit in September-2016 facility audit
• USFDA audit in May-2014 facility audit
• Hamburg (Germany) audit for the product Ramipril –March-2013
• COFEPRIS (Mexico) for the products Rabeprazole sodium, Levocetrizine HCl, Zoledronic acid, Esomeprazole, Ramipril, Trebinafine HCl & Pantoprazole in the year 2012
• EUGMP (Germany) for the Products Tacrolimus, Sirolimus and Mycophenolate mofetil in the year 2011.
• AFSSAPS (France) for the Product Fluvastatin in the year 2010.
• COFEPRIS (Mexico) for the products Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) & Recombinant Streptokinase in the year 2009.
• JFDA (Ministry of Health Jordan)for the products Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) & Recombinant Streptokinase in the year 2008.

• Quality Management system (Handling of Deviations, OOS, OOT, CAPA and Change management) and IPQA activities in Drug product and Drug substance manufacturing.
• Stability Management, QA interface for client relationships in a CDMO.
• Quality Audits and Compliance (Faced Regulatory audits such as EMA, USFDA, ANVISA, Health Canada etc.)
• Process Validations, Cleaning validations.
• Involving in monitoring of Equipment instrument qualifications and approval of the same (API manufacturing).
• Quality Risk management evaluations.