Job Description:
Responsiblefor AR&D for Formulations
Analytical method development for new Products for Assay, Dissolution, Content uniformity, Blend uniformity, TLC and RS etc.
Method validation As per regulatory guidelines.
Regulatory compliance levels monitoring in development.
Method transfers/Technology Transfers
Stability studies of the developmental products.
Development of technical skills in the team.
On-line support for FR&D
Equipment Qualifications, Calibrations
Training to new Joiners
Comparative Dissolution Studies
Forced Degradation studies
Preparation of analytical method validation protocols as per regulatory guidelines.
To close FDA deficiencies within stipulated time period for any activity to be done, method development, analysis, method validation etc.to submit the report to USFDA as per the committed time line.
Plant queries to be close as per the stipulated time period with scientific evidences and to help plant to close the OOS/OOT investigation reports so during audit same report should not come under any scrutiny from FDA auditor.
Periodical Calibration of various instruments like HPLC, GC, Dissolution, FTIR, UV-Visible Spectrophotometer, and Sartorius balances etc.
All validated test methods transfers from Analytical R&D to Quality Control.
Studying of In-vitro dissolution profile in different media of the both development sample and Innovator samples.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Analytical Chemistry Associate/Scientist
Role: Analytical Chemistry Associate/Scientist
Keyskills:
Analytical Researchanalytical research analystmethod developmentanalytical r&danalytical developmentadl researchadlanalytical analystAnalytical Research and DevelopmentFormulation
Desired Profile:
Candidates Must Have 2-10 Years FAR&D API Bulkdurgus / Formulation .
Education Qualification :MSc-Organic Chemistry /Analytical Chemistry .
Education:UG -B.Sc – Chemistry
PG – M.Pharma – Pharmacy, M.Sc – Chemistry
Doctorate – Doctorate Not Required
Company Profile:
MSN Group is one of the fastest growing manufacturers of Active Pharmaceutical Ingredients (APIs) and Finished dosages in India. Established in the year 2003, MSN Group comprises of eight API manufacturing plants ( including one for Oncology), two finished dosage facility ( one more for Oncology being built) and a dedicated R&D Center and is growing 30-40% every year. Our plants are ISO 9001-2000 certified, WHO: GMP, EU:GMP and USFDA approved. Our manufacturing units are designed to confirm to the principles of Quality, Safety and sound Environment.
Contact Details
Recruiter Name:Simhachalam
Contact Company:MSN Laboratories Ltd
Telephone:040-30438786
Address :Formulations Division ,Plot No:42, Anrich Industrial Estate, Bollaram ,Medak-502,Medak,Andhra Pradesh,India
Website:http://www.msnlabs.com