Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC.
Post : Formulation Analytical - NPD(DeveIopment, Validation. Transfers and Stability Studies)
Technical skills
• Must have Working experience with Analytical method development for Pre-formulations, Excipient and device compatibility studies
• Expertise in Analytical Validation of analytical procedures. Method transfers and Stability Studies for registration purposes (API, Solid Orals and parenteral formulation) by using HPLC, UPLC, GC with EMPOWER -3, Auto Tiltrotor, Particle size analyzers, UV, FTIRDSC, Particulate mater Analysisand Polari Meter.
• Must have abilities in Qualification, Calibration and trouble shooting of analytical instruments (list as above)
• Must work independently in drafting AMV protocols with appropriate study designs and accomplishment of final reports with conclusion, scientific rationale and dos& don'ts
• Knowledge in Computer System Validations will be an added advantage
• Must have applicable knowledge in cGMP, ICH, USP and regulatory requirements.
• Working experience in 21CFR part 11 compliance environment and Data Integrity practices
• Association with regulatory inspections such as USFDA, EUGMP, MHRA, IGA will be highly desirable
• Should be well versed with quality procedures and must have abilities to investigate laboratory incidents, OOS and OOT
• Working experience with multinational clients will be an added advantage
• Must have very good e - mail etiquette, oral & written communication skills
• Must possesses out of box thinking and Interpretational skills in drawing conclusions from development & validations
• Working experience with LC-MS/MS & GC-MS is desirable
Additional Information:
Experience: 1-3 years
Location: Hyderabad
Education: M.Pharm, M.Sc
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: Formulation Analytical
Walk in Interview
Date : 8th, October, 2017
Venue : Radisson Hyderabad, Gachibowli, Miyapur Road, Hyderabad, Telangana - 500032
Registration Timings: 8:30am to 10:30am
OR Apply/Send resume at, Harshitha.gowda@syngeneintl.com
See All Syngene Jobs M.Pharm Alerts Ph.D Alerts Bangalore Alerts
See All Other Jobs in our Database
.png)
