Lahu Ramling Gunjal, M.Sc. (Org. Chem.)

E mail: acxzi8@r.postjobfree.com; Mobile: +91-902*******

Seeking a technical driven role challenging profile that offers the opportunity to explore new avenues in the R & D by utilizing my domain knowledge

Profile Snapshot

Dynamic professional with 10+ years of exposure in the area of method development, validation and stability study with strong knowledge of ICH, EMEA, CDER FDA, PMDA Japan guidelines

Proactive and smart planner with expertise in strategic planning, data analysis and interpretation

Skilled communicator and a quick learner with analytical bent of mind coupled with zeal to utilize and enhance ideas, knowledge and skills

Exceptionally well organized with track record that demonstrates self motivation, creativity and initiative to achieve both personal and corporate goals

Multifaceted personality; passion for sports, reading and eating

Key Performance Areas

Hands-on experience on modern sophisticated instruments viz. HPLC, UPLC, IR, UV Visible spectrophotometer, Ion chromatography, Karl-Fisher-titrator (Metrohm), Dissolution apparatus (Electrolab, Labindia) etc. as well as other analytical techniques with strong knowledge of chromatography software viz. Dionex Chromeleon, Agilent Chemstation, Shimadzu LC Solutions and Class VP etc

Knowledge of cGMP, GLP and GCP guidelines

Well versed with Analytical method development, method validation, forced degradation, method deficiency queries, analytical method transfer, comparative dissolution profiling and stability studies.

Experience in dosage forms such as oral solids, ophthalmic solutions and injectables etc

Well versed in generation, maintenance and revision of SOPs, specifications, procedures, batch records, training, OOS and OOT investigations, data integrity and other documentation systems

Familiar with documentation system, as well as ANDA preparations and reviews and FDA regulations

Career Sketch

MACLEODS PHARMACEUTICALS LIMITED ( Markets : US, Europe and Japan)

Team Leader – Analytical R & D Since Oct -2008

Location : Macleods Pharmaceuticals Ltd., G-2, Saket building, New Onida

House, Mahakali Caves road, Shanti Nagar, Andheri (E), Mumbai - 400093.

Leading a group of Analytical method validation (API & Formulation) including 40 scientists and 20 HPLC, working on products for regulated markets

Looking into method development, method validation, method deficiency query, method equivalency along with method transfer to production units

Technical assistance and support to regulatory affairs department and different production units

Managing the developmental projects initiated by Formulation R & D department in the proposed agreed timelines

Ensuring successful transfer of analytical methods validated, to Quality Control department

Preparation and review of method validation protocols and reports, as well as release of all the analytical data generated

Conducting troubleshooting and investigations of analytical methods and modify analytical methods where needed

Ensuring on-line documentation and compliance to the set standard procedures

Technical assistance and support to regulatory affairs department and production units with respect to analytical data required for submission of ANDA filings

Coordination with inter and intra department teams, and conducting departmental meetings to ensure adherence to the agreed timelines and completion of the activities within the targeted timelines

Ensuring availability of all the facilities required for method validation activities

Imparting training to department colleagues on technical as well as non-technical subjects

Effectively and timely communicating with external customers

Periodic audits, revision and amendment of SOPs, and systems implementation as per ICH, GCP/GLP and international regulatory requirements

PROMED RESEARCH CENTRE ( Markets : Russia and CIS)

Research Associate – Analytical Development Laboratory May 2007- Oct 2008

Location : Promed Research Centre, 261, Udyog Vihar, Phase IV, Gurgaon -

122001, Hariyana.

Conducting analytical method development, method validation for ophthalmic solutions and method transfer.

Analysing stability samples and conducting stability studies of different ophthalmic solutions.

Preparation of stability protocol and compilation of stability data

Calibration of different analytical instruments.

CIPLA LIMITED (Markets : US, Europe)

QC OFFICER Jun 2005 - Dec 2006

Location : Cipla Ltd. Verna Industrial Estate, Goa.

Validating analytical methods and conducting forced degradation studies for different drug products as per ICH and regulatory guidelines

Analysis of Raw material, Finished Products and Stability samples using HPLC systems.

Preparation of Validation protocols and reports

Performing Dissolution testing of different solid oral dosage forms

Preparation of SOP for Analytical Instruments

Calibration of Analytical Instruments

Acheivements

Audits faced: US FDA, MHRA UK, WHO Geneva, ANVISA Brazil.

Awards

Shivaji University merit scholarship

Trainings and Workshops

Seminar given by Sotex corp. on dissolution testing.

Training given by Shimadzu on analytical method development and validation.

Qualifications

M.Sc.(Organic Chemistry)

Shivaji University Kolhapur, Maharashtra, Science

2003-2005

68.96 %

B.Sc.(Chemistry)

Shivaji College Barshi Shivaji University Kolhapur, Maharashtra, Science

2000-2003

79.40 %

H.S.C.(Science)

Shivaji College Barshi, Pune Board, Maharashtra.

1999-2000

65.17 %

S.S.C.

Lokmanya Vidayalay Mankeshwar, Aurngabad Board, Maharashtra.

1995-1996

62.66 %

Additional Information

Date of Birth 20 August, 1981

Marital Status Married

Computer Proficiency Knowledge and experience of Windows 7, MS

Word, MS Excel, using email and the internet

Languages known English, Hindi and Marathi

Nationality India

Contact address Gokul Angan CHS, Flat no.403, plot-60, sec-20, kamothe, near aishwarya hotel, navi Mumbai-410209, maharashtra.

Phone number +91-902*******

References 1. Mr. Senthilkumar, General Manager, Macleods

Pharmaceuticals Ltd., Phone: +91-900*******.

2. Mr. Dilip Kamble, Team Leader, Macleods

Pharmaceuticals Ltd., Phone: +91-773*******

Contact this candidate