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Senior Professional-Quality Assurance & Control Preferred Industry: Bio pharmaceutical/Pharmaceutical/Agriculture Location Preference: Denmark/Schengen countries(*Received Denmark GR 1 and work permit visa. Arrived in Copenhagen by Dec 30th,2015) Contact numbers in Denmark: +4571530681 or +447452117165 Contact Address: Room # 407, Rent A Room, NORREBROGADE 51, 2200 Copenhagen N,0045/26212939 E-Mail: A result-oriented professional with strong acumen and technical expertise in quality systems to deliver desired output with good decision making, team management & leadership skills. Profile Summary >A dynamic person with more than 17 years of experience in Quality Control, Quality Assurance, Program / Project Management and Agriculture, specifically in Biopharmaceutical/Pharmaceutical Contract Research and Government sectors. >Worked on successful commercialization of 4 molecules including a mAb, a sialylated protein and 2 microbial biosimilars. >Led Biochemistry, Microbiology, Raw material &Packing material testing, and cGMP Warehouse sections of Quality control as Section head; ensured timely lot release of 4 Biosimilars. >Competent in implementing lean QC testing, reducing TAT (turnaround time) and ensuring timely delivery of batches of commercial biosimilars. >Expertise in analytical method validations and quick grasping ability about new technical concepts & implementation of the acquired knowledge in a productive manner. >Successfully completed audits such as ISO, NABL, CDSCO, ANVISA, INVIMA, GCC, WHO, ANMAT etc. as well as Technology transfer to external clients as QC-QA Compliance Lead >Well versed in Quality assurance systems such as CAPA (Corrective and Preventive action), Discrepancy management, OOS (Out of specification), Deviations etc. >Proficient in conducting internal audits, document management systems and testing for Process and Cleaning Validations with excellent interpersonal & communication skills .


Past Experience

  • Manager
    April 2007 --- December 2015
    >Led Biochemistry, Microbiology, RM/PM, cGMP Warehouse; ensured timely lot release of 4 commercial products. >As Compliance Lead, established any day audit readiness of QC and closure of all QC related quality systems issues on time along with QA counterparts(DMS,OOS,CC,PD etc) > Successful completion of analytical method validation of products for commercial launch. >Ensured the smooth functioning of Quality control, Biologics even in the absence of HOD’s during transition periods as department in charge. >Release of Certificate of Analysis (COA) of products on time as DCGI approved analyst by timely review and release of batches. >Designed & implemented 8 horizontal projects & 9 skill matrix training modules in 2013-2014 for QC department. >Involved in cross functional skill enhancement in QC, knowledge management, training and horizontal growth of the QC employees in other technical areas. >Completed a project on technical package creation called ‘DRL Biologics Bioscience on Quickr’ for all products available at Biologics for the higher management. >Ensured Project management of Operations council projects.Integrated oversight and tracking of the portfolio and programs assigned to the Programs management office. >Development and management of the process and systems of program and project management. >Integration of program planning, processes, monitoring, execution and tracking updates. 

  • Magene Life sciences
    April 2004 --- April 2007
    Key Responsibilities: Assay Development >Analysis and screening of potential therapeutic drugs for various projects using HPLC. >Worked in assay development using HPLC and ELISA for various small molecules. Genetic Engineering >Cloning and expression of various therapeutic proteins in bacteria and yeast vectors for customers. Quality Assurance >Responsible for meeting the GLP requirements and necessary up gradations for enabling NABL and ISO certifications of the organization also for the process & documentation simplifications in QC leading to more user friendly systems. . Resource Management >Retrieved Scientific, IP and related data for the entire scientific team, in charge of library and preparation of library budget for each financial year. >Managed the journal club & organised guest lectures for MLS staff. As Environment Safety/ Waste Management: >Worked as Environmental Safety Officer of MLS; ensured safety by disposal of wastes like radioactive materials.

  • Dr.Barwale's research foundation
    September 2003 --- April 2004
    >Led a Virology project “Strategies to identify and limit the impact of Tobacco streak virus in India”. >Determined the biodiversity between various TSV isolates infecting target crops –Groundnut and Sunflower. >Developed diagnostic tools like ELISA and RT-PCR for detecting and characterized various TSV isolates. >Developed pathogen derived resistance by incorporating the coat protein gene of TSV into target plants.


LinkedIn Assessment :
MicrobiologyBiochemistryQuality ControlQuality AssurancecGMP manufacturingAnalytical Method ValidationProject ManagementProgram ManagementRegulatory Compliancemolecular biologyBiotechnologyAgricultureBiosimilarsWorkplace SafetyAuditingCROCross-functional team leadershipOperations ManagementLean ManagementCost PlanningBiopharmaceuticalsPharmaceutical IndustryPlant Breeding


  • Doctor of Philosophy (Ph.D.) in Microbiology, Biochemistry, Molecular Biology and Biotechnology from Indian Agricultural Research Institute in 1998
  • Master of Science (MSc) in Microbiology, General from Indian Agricultural Research Institute in 1998
  • Bachelor’s Degree in Agriculture, Agriculture Operations, and Related Sciences from College of Agriculture, Vellayani in 1992

Area / Region



Driving License
  • No