Career opportunity for Executive in Rubicon Research

Rubicon Research is a product development company based in Mumbai, India and is recognized as a world class outsourcing partner in pharmaceutical industry, serving Fortune 500 companies worldwide. We are a fast growing, young organization of 250 employees with significant experience in the field of formulation development and providing a full spectrum of development services from preformulation to registration. We also have our GMP manufacturing plant from where we provide commercial supply chain.

Post: Executive, 4

Job Description
-To draft a strategy document outlining a road map for the Project under development and get its approval from respective Clients.
-To complete the requisite check list for the Project and identify material resource requirements w. r. t. quality and quantity.
-To source the right quality of the API and excipients required for all the experiments within the Project scope.
-To liaison with the Analytical Group for the regular analysis of the samples generated from the experiments.
-To ensure the proper documentation in the laboratory note books and regularly review the documentation for accuracy and legibility.
-To compile the experiments in relevant document formats as dictated by the regulatory guidelines and client directives or project scope.
-Execute the scale up activities in liaison with department manager for all allocated project- wherever applicable.

Candidate Profile
Job specification:
-Good understanding/knowledge of regulatory guidelines or regulations.
-Good experience working in regulated market.
-Exposure to regulatory audit like MHRA, USFDA, ANVISA, TGA, etc.
-Must have good scale up experience
-Should have strong skills in PDR writing (CTD format)
-Candidates with 5yrs+ exp should be currently leading a team of at least 2-3

Additional Information:
Experience: 5+ years
Location: Bhandup, Mumbai
Industry Type: Pharma/Biotech/Vaccines
Last Date: 30^th August, 2014