I am in quest of senior level assignments as Functional Lead - Quality Control/ Quality Assurance with an organization of repute in Denmark or nearby Schengen countries.

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Profile Summary
 A dynamic professional with more than 17 years of experience in Quality
Control, Quality Assurance, Program / Project Management, Agriculture
specifically in Biopharmaceutical, 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, RM/PM and cGMP Warehouse sections of
QC; 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 versedinQAsystemssuchas CAPA(CorrectiveandPreventiveaction),
Discrepancy management, OOS(Outof specification),Deviations etc.
 An enterprising leader with skills and expertise in managing large teams,
during the professional tenure.
 Proficient in conducting internal audits, document management systems
and testing for Process and Cleaning Validations.
 Integrated oversight and tracking of the portfolio/ programs/projects at
initiation, planning, monitoring and execution phases.
 Excellent interpersonal & communication skills with strong abilities in
people management and maintenance of stakeholder relationship.
Core Competencies
QC & QA operations
Biosimilars
Small molecules
Analytical Method Validation
Research & Development
Project & Program Management
Quality Systems & Audits
Liaison & Coordination
Team Management
Training & Development
Soft Skills
Personal Details
Date of Birth: 13th May 1969
Languages Known: English, Hindi, Malayalam,
and Tamil
Present Address: Room#407, Rent A Room,
NØRREBROGADE 51,2200 Copenhagen
N,0045/26212939
Education
Ph.D (Microbiology) from Indian
Agricultural Research Institute (IARI), New
Delhi in 1998.
M.Sc. (Microbiology) from IARI, New Delhiin
1994.
B.Sc. (Agriculture) from College of
Agriculture, Vellayani, Kerala in 1992.
ANNE ROSHAN JOSEPH (Ph.D)
Senior Professional
Quality Assurance & Control
Preferred Industry: Biopharmaceutical/Pharmaceutical/Biotechnology/Agriculture
Location Preference: Denmark/Schengen countries(CPR received)
(*Received Denmark GR1visa and work permit visa and arrived in Copenhagen on Dec 30th, 2015)
Contact numbers in Denmark: +4552905730 or +447452117165 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

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Work Experience
Since Apr’07-Dec’15 with Dr.
Reddy’s Labs,
Biologics Development
Centre, Hyderabad
Growth Path:
Jul ‘13-Dec’15 as Manager
(Program and Projects
Management)
Nov ’09 –Jul’13as Manager (Quality
control and assurance)
Apr’07-Nov’09 as Deputy Manager
(Quality Control)
Previous Experience
Sep’04-Apr’07 with Magene Life
Sciences, Pvt., Ltd., (MLS),
Hyderabad as Scientist
Sep’03-Apr’04 with *Dr. Barwale’s
Research Foundation, Hyderabad as
Scientist (Plant Virologist)
(*Previously Known as Mahyco
Research Foundation)
2002-2003- Michigan State
University(MSU), East Lansing with
Dr. C. Adinarayana Reddy in a US-
DOE funded project on
bioremediation
2001-MSU, East Lansing with Dr.
Frank Dazzo in a project on
endophytic rhizobial strains of
Wheat
Sep’98-Jul’00 with Sugarcane
Breeding Institute, Coimbatore as
Research Associate, Microbiology
Highlights:
 Recipient of:
o DRL Best Team Lead Award for innovation in 2014 for ‘QC Knowledge Sharing
Systems’.
o DRL Best Team Award for Safety-Employee engagement program” in 2013.
o DRL Best Team Award for the successful completion of all external audits in
2009.
 Qualified the NET (National Eligibility Test) for lecturer ship / Assistant
Professorship conducted by Agricultural Scientist Recruitment Board of ICAR
(Indian Council of Agricultural Research), New Delhi in 1999.
 Received the I.A.R.I. Merit Medal for outstanding performance for PhD thesis work
(1999).
 Secured Senior Research Fellowship from ICAR (1994-1998).
 Achieved Junior Research Fellowship from ICAR (1992-1994)
 Recipient of Merit Scholarship from KAU (Kerala Agricultural University),1987-
1992.
 Skilled in regular Quality Control operations using standard operating procedures
as per cGMP and cGLP norms for ensuring smooth establishment of product
commercially.
 Completed analytical method validations of 2 commercial products (OD 280, SDS-
PAGE, IEF, Western blotting, ELISA and RT-PCR) in QC Biochemistry, as section
head; timely validation and completion of Biochemistry assays helped in dossier
filing and specifications setting of the products.
 Played a key role in timely completion of TOC (Total organic carbon), Cleaning
Validation testing, BET (Bacterial endotoxin test) validations, Media fill studies of
drugs products as the section head of QC Microbiology section for 4 biosimilars.
 Coordinated the “Cost per assay / product for QC assays “project, a QC initiative for
HOD in 2010.
 Contributed to the equipment qualifications, annual product and process quality
reviews as a reviewer and self-inspections of QC, QAand c GMP WH (Warehouse) in
DRL as an auditor from 2007 to 2013.
 SuccessfullyimplementedKPI(Key PerformanceIndicators) forQCalongwithIBM team;
initiatedfirewall softwareforQC’sdocumentsafety /protection.
 Effectively organized & implemented cost centers, mobility policies and legal
document trackers for entire Biologics Operations.
 Single handedly imparted cross functional technical knowledge in QC personnel by
implementing 9 skill matrix modules and 8 horizontal projects (products and
systems improvement) in QC, resulting in reduction of attrition rate of the
department.
 Efficiently identified gaps invarious areas of Biopharmaceutical industry as QC-QA compliance
lead that helped insubsequent corrective & preventative actions inrespective areas.
 Empowered subordinates by handholding and enhanced skill development as future
managers.
 Guided technology trainees (MSc students) for their projects and dissertations
leading to completion of their post-graduation.
 Led the implementation of new systems in QC and devised risk mitigation of Raw
Materials / Packing Materials testing and final products.
 Ensured sufficient availability of approved RM/PM & consumables in cGMP WH
(Ware house) and its efficient utilization in production by proper inventory
planning and execution.
 Played a key role as QA manager in achieving ISO (ISO 9001:2000) & NABL (ISO
17025:2005) accreditation to the company (Magene Life sciences); actively involved
in successful surveillance audits.

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 Modified the testing systems, flow of materials and reduced the TAT (Turnaround time) in RM and PM labs to improve the
timely availability of materials for production purpose as per pharmacopoeia
 Completed a technical package creation in Quickr titled ‘DRL Biologics Bioscience’ for all products available at DRL,
Biologics for the higher management.
 Project and program management of various products and non -products of Dr. Reddy’s Biologics unit. Analysed project
data by trending of Budget vs Costs & spent, CAPEX and KPI (Key Performance Indicator).
 Attended training in CAPM (Certified associate for project management) and PMP (Project management professional).
 Successfully involved as analyst in HPLC based analytical method validation of 20 potential drug molecules (small
molecules) for a customer at Magene life sciences (MLS), Hyderabad.
 Cloning of various gene sequences in vectors (bacteria and yeast), based on customer needs through genetic engineering
techniques as Project Scientist in MLS.
 Involved in HPLC based method validation of 20 small molecules for a customer at Magene Life sciences.
 Determined the biodiversity between various TSV (Tobacco streak virus) isolates infecting target crops –Groundnut and
Sunflower at Mahyco Research foundation.
 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.
 Displayed excellence in mass production & distribution of bio fertilizers for sugarcane farmers; strain improvement of
biofertilizers and biopesticides at Sugarcane Breeding Institute.
 Successfully trained in ISO 9001:2000 and NABL (ISO/IEC 17025:2005) quality policies. Certified Internal Auditor for both
certifications.
 Trained in c GLP/ c GMP practices and regulatory guidelines for sterile drug manufacturing.
 Well versed in preparation of program briefing book, internal and external communication reports.
 At Michigan State University, USA, with Dr. Frank Dazzo devised an autecological biogeography index to map the
distribution of a specific strain of Rhizobium. sp on a macro scale, based on immunofluorescence microscopy of nodule
occupants on legume trap crops using CMEIAS software.
 In addition, at MSU with Dr. Adinarayana Reddy I contributed to a USDOE funded project for the construction of
Ganoderma lucidum genomic library and isolation of a laccase gene sequence, useful in bioremediation of environmental
pollutants.
ANNEXURE
TECHNICAL EXPERTISE
Microbiology
Microbiological: Aseptic microbial techniques, Microbial Taxonomy, Biochemical tests, BET, Bioburden,
sterility testing, facility monitoring (water and environment), Media fill and Respirometry.
Mass production technologies: Biofertilizers and Biopesticides production (strain improvement & culture maintenance).
Microbiological Assays: Cellulolytic, lignolytic, hemicellulolytic, antibiotic and soil microbiology assays. Serological
and immunological techniques like ELISA, Dot blot immunoassay and precipitation tests.
Biochemistry
DNA manipulations: Isolation & purification of DNA from plants and microorganisms, restriction digestion,
cloning, PCR, DNA sequencing, Southern blotting (Slot and Dot blotting) Transformation
(Chemical & Electroporation), Conjugation, Transfection, Agarose gel electrophoresis, Phage
Typing, Nucleic acid hybridizations, Real time PCR & detection of Mycoplasma
contamination.
RNA Manipulations: Isolation and purification of plant, bacterial and viral RNA.

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Protein techniques: SDS-PAGE, protein estimation by Absorbance at 280nm, Western blotting, IEF, Protein
estimation -Lowry’s method /Bradford’s assay using UV-Vis Spectrophotometer.
Chromatography RP-HPLC- based sample analysis, Method development, Method validation and stability
studies of different small molecule drugs, GLC, Gel chromatography and TLC.
Other Techniques Raw material analysis (Colorimetry, Polarimetry, melting point, FTIR etc)
Research Work & Thesis
 Contributed to a US-DOE funded project for the construction of Ganoderma lucidum genomic library and isolation of a gene
sequence, useful in bioremediation from Michigan State University (MSU), East Lansing with Dr. C. Adinarayana Reddy
during 2002 -2003.
 In 2001, completed a project from MSU, East Lansing with Dr. Frank Dazzo on Quantitative autecological biogeography
index for determining the relative abundance of an endophytic rhizobial strain in root nodules.
 Accomplished the completion of Ph.D thesis titled ‘Pyrite amendment & inoculation of iron-sulphur oxidizing bacteria to
Canola & Wheat’ at Indian agricultural research Institute, New Delhi in the period 1994-1998 with Dr. K.V. B. R .Tilak.
 Completed MSc thesis ‘Effect of Benomyl & Diuron on soil microbial activities’ at Indian agricultural research Institute,
New Delhi with Dr. S. P. Magu during 1992 – 1994.
Posters & Publications
 Anne R Joseph, Suresh K Kavimandan, Kolluru V B R Tilak and Lata Nain (2014). Response of sulphur oxidising bacteria on
Canola and wheat crops in pyrite amended soil. Archives of Agronomy and Soil science 60(3):367-375.
 Dazzo, F. B., Joseph, A. R., Gomaa, A .M., Yanni, Y. G., & Robertson, G.P.(2003)-Quantitative indices for autecological
biogeography of Rhizobium endophyte of rice at macro/micro spatial levels. Symbiosis. 35: 147-158.
 Yanni, Y.G., Joseph. A. R., Gomaa, A. M., Squartini, A., Trione, D., Maya-Flores, J., and Dazzo, F.B (2002). Autecological studies
on the Rhizobium leguminosarum bv trifolii/cereal root association in cropping systems involving rice and wheat in Nile
delta. Presented at 9th International symposium on nitrogen fixation with non- legumes. Sep 1-5, Leuven, Belgium.
 Joseph, A. R and Magu, S. P (1998). Effect of Benomyl and Diuron on soil microbial activities. Poster at Association of
Microbiologists of India diamond jubilee conference held at Mangalore, India.
References
 Can be provided on request