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Summary

Alba Casta Pharma Solutions, India is a trading and auditing company for bulk Pharmaceuticals and advanced intermediates manufactured in India. We cater to the need of overseas customers and provide some of the unique services to our customers. We are professionally managed firm, having experienced pharma professionals in our panel. We look after: - International trading in bulk drugs and intermediates. - In- and Out-Licensing. - Scientific liasoning. - Audits (planned and unplanned) of bulk drug manufacturers. - Supply chain management. - New vendor development. - Medical writing/CMC writing. - Regulatory affairs.

Experiences

Current Experience

  • Founder & CEO
    Since January 2015
    Alba Casta Pharma Solutions, India is a trading and auditing company for bulk Pharmaceuticals and advanced intermediates manufactured in India. We cater to the need of overseas customers and provide some of the unique services to our customers. We are professionally managed firm, having experienced pharma professionals in our panel. We look after: - International trading in bulk drugs and intermediates. - In- and Out-Licensing. - Scientific liasoning. - Audits (planned and unplanned) of bulk drug manufacturers. - Supply chain management. - New vendor development. - Medical writing/CMC writing. - Regulatory affairs.

Past Experience

  • Sr. Manager, ARD
    April 2011 --- January 2015
    Analytical Method development, Analytical method validation, Regulatory Queries and analytical derivatization.

  • Senior Manager ARD
    April 2011 --- January 2014
    About 18 years of experience in analytical chemistry covering method development, validations, regulatory queries, genotoxic studies and analytical derivatizations. My major responsibilities are as follows: 1. Analytical Method Development. 2. Analytical validations (HPLC, GC, GC-MS & LC-MS). 3. Regulatory queries (USFDA, EDQM, MHRA, IDL-China, KFDA, PMDA). 4. Customer complaint handling. 5. Have integrated experience of developing High Potency APIs (HPAPI), Cytotoxic and Steroids. Product development: Non-Beta:Successfully completed the analytical part of the following molecules viz., nateglinide, fluvastatin sodium, clopidogrel besylate, residronate sodium, rimonabant, ezetimibe, dapoxetine hydrochloride, exemestane, prulifloxacin, anastrozole, letrozole, dutasteride, imatinib mesylate, candesartan, Bortizomib, pentazocine, Pentosan Polysulfate Sodium (PPS), vildagliptin, sitagliptin, danofloxacin, strontium ranelate, atracurium besylate, uramustine and azasatidine. Cephalosporins & Penicillins: Ceftibuten trihydrate, Cefdinir, Ceftaroline fosamil, piperacillin & tazobactum, sulbactam sodium, Ceftiofur, Cefixime trihydrate. Participated in USFDA audit (for clarithromycin), Hungarian Drug Authority’s audit (for anastrozole) and addressed Romanian, UK, France, TGA and Poland Drug Authority’s analytical quarries. Performed audits of advanced intermediate manufacturers for GLP compliance. Performed more than 300 analytical validations (HPLC, LC-MS, GC-MS & GC). Practical training on separation of natural products, Radioisotope techniques like GM Counter, Gamma Ray Spectrometry, Liquid Scintillation Counter, Radio-TLC etc. Core competencies - Good interpersonal and communication skills. - Deft in planning, managing and executing projects. - Handling various aspects of a project like documentation, experiment design and integration of analytical, synthetic and regulatory issues. - Delivering the projects as per the timelines.

  • Sr. Scientist-II, ARD
    September 2004 --- January 2011
    Analytical method development, analytical method validation, regulatory queries and analytical derivatization.

  • Sr. Manager, QC
    May 2003 --- July 2004

  • QC Officer
    November 2000 --- December 2002

  • Senior Research Fellow
    June 1999 --- November 2000

  • Research Associate
    October 1996 --- July 1997
    Worked as Research Associate (synthesis) in a project funded by Ministry of Non Conventional Energy Resources. We used to perform trans esterification reaction on non-edible Mahua oil (Madhuca longifolia) which is produced in Madhya Pradesh. After trans esterification, the resultant product can be mixed in HSD (High Speed Diesel) in the ratio up to 40%.

Knowledge

LinkedIn Assessment :
V&VGC-MSChromatographyR&Dgas chromatographyMass SpectrometryLC-MSRegulatory RequirementsQuality Control (QC)SOPMethod developmentCleaning ValidationValidationANDASOPPharmaceuticsLife SciencesCAPAQuality SystemsRegulatory submissionsQuality Assurance (QA)Change ControlUV/VisOrganic SynthesisTechnology transferGood Laboratory Practice (GLP)Organic ChemistryHPLCSciFinderPharmaceutical IndustryChemistryFDARegulatory affairsAnalytical Method ValidationAnalytical DerivatizationsAnalytical ChemistryGMPCMC reviewer of Module 3 of CTD

Education

  • Ph.D. in Chemistry from Ph.D. in Chemistry from MJP Rohailkhand University, Bareilly, INDIA in 2004
  • Master of Science (MSc) in Agricultural Chemicals (Pesticide Science) from Pantnagar University in 1994

Training and Certification

  • 37th National Work-Shop on Radiochemistry and Application of Radio-isotopes Certification
  • HPLC <621> in USP Monograph Certification
  • Quailty Management Systems Auditor/Lead Auditor Training Course ISO 9001:2008 Certification

Area / Region

Chandigarh, India

Others

Driving License
  • No