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Summary

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: anneroshjos@gmail.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 .

Experiences

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.

Knowledge

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

Education

  • 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

Denmark

Others

Driving License
  • No

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