Job for M.Pharm, M.Sc in New drug product development at Syngene International

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 : NPD

Job Description
• Preparation of documents like Protocols, ODS, Reports, Familiarization, validation, Qualification and to ensure compliance with respect to BGRC and Baxter Quality requirements.
• Execution of analytical validations activities with respective of approved protocols validation of NPD ( New drug product development).
• Calibration and maintenance of Equipment / instrument.
• Responsible for online documentation adhering with GDP practice.
• Execution of daily lab activities and maintain the lab as per CGMP standards.
• Adherence to Good Laboratory Practice.
• Verification of chemicals along with checklist before starting analysis.
• Responsible of procurement of chemicals/reagents required for execution.
• To follow cGMP, GDP, GLP, and Regulatory compliance.
• Responsible for initiation like change control, Incident and deviation etc...
• EHS training & compliance.
• Attend mandatory trainings as and when conducted.
• Experience in parallel bioassays
• Experience in blood factor assays like Factor Xa and IIa for Heparins and Low molecular Heparins
• Knowledge in OOT,OOS
• Knowledge in Bioassays like parallel Bioassays for Blood coagulation factors
Working experience in cGMP/GLP environment and USFDA audits and thorough knowledge in ICH guidelines

Candidate Profile
M.Sc /M.Tech/M. Pharmacy
Minimum 3-6 Years
TECHNICAL /FUNCTIONAL SKILLS:
Should have very good communication skills
Operation skills in Multi plate readers, Parallel bioassays, estimation of blood coagulation factors like Xa,IIA HPLC,ICP
Should be familiar with cGMP and ICH guidelines and related compendia procedures

Additional Information
Qualification : M.Sc, M.Pharm
Location : India
Experience : 3-6 years
Industry Type : Pharma
End Date : 10th October, 2018