Quality Control Assurance

NIKHIL SUBHASH PORE

***, *********, **** *****, ************, Dombivli (w), Thane, India -421202

Email –******@*******.***, ******@**********.***, Mobile: +97-976*******

Experienced pharmaceutical analyst with sound knowledge of research and development. Curiosity, the thirst to know more, not just content with what are told, and get delighted in applying knowledge into better insights at work and Passion, the infectious enthusiasm to complete the job on hand and the ability to stimulate others with it.

SKILLS & ATTRIBUTES

• Good written and verbal communication skills.

• Ability to work to objectives, timelines and budgets.

• Working knowledge of MS Word & MS Excel.

• Ability to work independently and also within a team.

• Attention to detail

WORK EXPERIENCE

Dec 2009 – Current Rubicon Research Pvt. Ltd Mumbai, India

Officer Analytical

Rubicon Research private ltd is CRO for leading in innovation for pharmaceutical companies around the world. The role involved conduct appropriate analysis and to report data in accordance with regulatory guidelines (GMP, ICH, MHRA and FDA standards) and the requirements of project contracts and/or technical agreements assigned to the Analytical Chemistry Department.

• Analytical experience:

• Developing HPLC methods for API, intermediate, in-process and finished products.

• Conduct analytical method development, method validation and method transfer for Dissolution, Assay and RS methods.

• Provide analytical support for product development by performing analysis on newly developed product, excipient compatibility and dissolution.

• Extensive routine and stability analysis on Tablets, Syrups and Capsules dosage forms which included Assay and Related substances, determination of water content using Karl Fischer, Uniformity of weight and content, Dissolution testing and other pharmacopoeial tests.

• Carrying out stability trend analysis to identify potential behaviour at various stability time points.

• Instruments used: Major work carried out on HPLC, FT-IR, UV Spectroscopy, Dissolution apparatus DSC, Karl Fischer Titrimeter, Viscometer.

• Documentation and Additional responsibilities:

Preparation of GMP documents which included Analytical protocols, Analytical Method Development Report (AMDR), Method of analysis (MOA), Analytical/Validation reports, Deviations, Change controls, Laboratory investigation reports, Technology Transfer Document (TTD) (like Tech transfer protocols and reports), preparation of various technical documents like specification including In-process Specification (IPS), Intermediate and Finished Specification, Product Development Report (PDR), required for the execution of the validation/commercial batches and other pharmaceutical development forms and Dossier Preparation.

• Trained new personnel with analytical instruments and client specific methods in accordance with training protocols and SOPs.

• Additional responsibilities also included checking and verifying of analytical data of colleagues to completeness and GMP standards.

• Job role also involved communicating, co-ordinating and updating other departments like QA, stability management, instrument maintenance and clients on regular basis.

• Ability to handle projects independently and within a team.

Oct 2006 – Aug 2007 Laboratories Griffon Pvt. Ltd. Mumbai, India

Chemist

An excellent opportunity to work with one of world leading Indian pharma company. Work involved testing various pharmaceutical formulations.

• Preparation of Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs). according to the CTD format for preparation of dossier file.

• Worked as Acting Supervisor for the team of fifty peoples.

• Checking of quality control parameters during preparation of Liquid and Tablet dosage forms.

• Job role also involved communicating, co-ordinating and updating other departments like QA, stability management, instrument maintenance.

• Maintaining and checking documentation, request amendments if required.

May 2005 – Jun 2005 MJ Biopharm Pvt. Ltd Navi-Mumbai, India

Industrial Placement

Placement student to learn detailed formulation and manufacturing process of Parentrals Ointments, tablets, solution etc on commercial scale and an opportunity to work with QC department to carry out day to day analysis.

• Achieved understanding for formulation and commercial production of parentrals tablets, syrup solution, granules and ointments.

• Worked with QC (quality control) on HPLC (which included analysis of active content and stability testing of pharmaceutical products, in the GMP and GLP environment), IR, UV spectroscopy and gained experience in wet chemistry and Titrimetry. All the tests were carried in accordance with GMP standards.

• Conducted manual/automated titration, disintegration test, physical test on tablets like friability & hardness and inorganic test like sulphate content.

• Achieved understanding for Stores, special arrangements for Under test, process and finished products

• Understanding of BMRs, BPRs and in-process checks.

EDUCATION

Masters in Pharmaceutical Chemistry (First class)

2007 – 2009 University of Pune Pune, India

Major subjects: Advanced Analytical Techniques, Advanced Pharmaceutical Chemistry , Advanced Medicinal Chemistry, Drug Design , Advanced Quality Assurance Techniques (cGMP & Documentation) , Drug Regulatory Affairs , and Research Methodology.

Project Work:

• Design, synthesis, characterization and evaluation of potent NSAID’s.

• Development of HPTLC method for the estimation of Paracetamol, Diclofenac Sodium and Chlorzoxazone in Bulk and Tablet dosage form.

• Development of HPTLC method for the estimation of Cefixime and Cloxacillin in Tablet Dosage Form.

Training:

• Pursued Training for method design and optimisation technique.

• Pursued Training for different Analytical Techniques like NMR (Nuclear Magnetic Resonance), HPLC, HPTLC, FTIR (Fourier Transform IR Spectroscopy) and etc.

• Performed Calibration of analytical instruments like UV-Vis Spectrometer, pH meter and weighing balances.

Bachelor of Pharmaceutical Sciences (First class)

2002 – 2006 University of Mumbai Mumbai, India

Major subjects: Pharmaceutics, Pharmaceutical chemistry, Pharmaceutical analysis, Pharmacology and toxicology, cosmetics, Hospital Pharmacy, Pharmaceutical Management.

SEMINAR PRESENTED

• Represented seminar on “Autoimmune Diseases”

• A seminar on “Recent Trends in NSAID’s”.

• A seminar on “Structural Based Drug Designing of Selective COX-2 Agents”

• Seminar on Design, Synthesis and Evaluation of Thiazole Derivatives a potential NSAID’s ”

PUBLIACATIONS

• Research article published in Asian Journal of Chemistry on “Development of HPTLC method for the estimation of Paracetamol, Diclofenac Sodium and Chlorzoxazone in Bulk and Tablet dosage form”.

• Research article published entitled as “HPTLC Estimation of Cefixime and Cloxacillin in Tablet Dosage Form” in Asian Journal of Research Chemistry 3(2): April- June 2010.

PERSONAL

• Date of birth : 29th Jul, 1984

• Gender : Male

• Marital status : Unmarried

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