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: email@example.com 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 .
ManagerApril 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 sciencesApril 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 foundationSeptember 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 :
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
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