Recruitment Drive for Analytical Department & Quality Assurance 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.

Analytical Department
Experience: 2 to 7 Years
Qualification: M.Sc./M. Pharm
Technical Skills:
> Expertise in Analytical Method development, Method Validation, Method transfers and stability studies (API, Solid Orals and parenteral formulation) by using HPLC, UPIC, GC with EMPOWER
> Excellent knowledge in cGMP, ICH, USP and regulatory requirements and good oral & written communication skills.
> Working experience in 21 CFRpartll compliance environment and should be well versed with ICH guidelines & US FDA guidance documents
> Associated with regulatory inspections such as USFDA, EUGMP, MHRA, TGA will be an added advantage v Should be well versed with quality procedures and must have abilities to investigate laboratory incidents, OOS and OOT
> Please note that QC candidates with hands on experience in Method Validation & Transfers can also apply

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Quality Assurance (Formulation/Biologics/API manufacturing)
Experience: 2 to 9 Years
Qualification: M.Sc./M. Pharm with experience in relevant field
Technical Skills:
- Experience in the QA activities for Biopharmaceuticals, API manufacturing and Solid oral dosage manufacturing.
- Handling of change controls, deviations, CAPA, OOS, OOT, incidents, risk assessment and failure investigations
- Involvement in Process validation, cleaning validation/verification and hold time studies
- Review of executed batch records, master formula records, support documents and Technology transfer documents
- Line clearance for product changeover in GMP manufacturing activities
- Review of SOP pertaining to equipment operation and manufacturing activities

Date : 02 July 2017 (Sunday)
Venue: The Gateway Hotel, 309,
Old mahaballpuram Road,
Shoiingonallur Chennai - 600119

Registration Timings: 8.30-10.30 AM

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