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CIEL/SEL/23441: Analytical Research and Development in API Industry - Hyderabad
Hyderabad . Telangana . India
Posted 800 days ago
Job Summary

AREAS OF RESPONSIBILITY (AOR) Analytical Method Development & Validation:

 · Collect the required literature for API as and when the new project comes and drug product to develop robust and rugged analytical methods as per regulatory requirement IN ORDER TO characterize the product quality. 

· Prepare protocols for validation once the product is finalised, to ensure the availability of columns, impurities, samples and standards to initiate and complete validation IN ORDER TO fulfill the validation as per regulatory requirement (ICH guidelines, etc..) In-process and R&D stability Samples Analysis & Documentation: 

· Everyday analyse the development batch samples and R&D stability samples IN ORDER TO give continuous support to formulation department to meet target product profile as per regulatory requirements.

 · Complete online worksheets with respect to daily experiments; prepare AD STPs, Method Development Reports, Analytical reports and QC STPs, whenever the product is finalised IN ORDER TO provide analytical reports, stability compilation and validation reports. 

 

Analytical Method Transfers: · Team Member execute the process of Transfer of Analytical Methods within the Organization as well as to external parties like CROs and CMO and Team Leader ensure IN ORDER TO facilitate successful transfer of technology.

 

 Compliance to GLP and safety: · Maintain GLP (good laboratory practices) , GDP (good documentation practices) and safety by checking the instruments and maintenance on regular basis in the analytical laboratory IN ORDER TO adhere to SOPs, safety & compliance.

 

 MINIMUM REQUIREMENTS: Education & Experience : 

M Sc Chemistry . with 6 year of industrial experience, Directly worked on method development and validation relevant to AR&D for at least 1-2 products/projects 

 

Implemented a new technology like HPLC to be used in area of expertise Participated in successful method transfer of at least 1-2 products 

 

Collaborated with regulatory affairs team in successful filing for at least 1-2 products

Skills
"analytical development", "method development", "method validation", "HPLC", "GLP", "GDP", "SOP", "analytical method transfer"
Recruiter Info
Keerthana RS
keerthana.rs@cielhr.com
About Us
CIEL HR Services

CIEL recruits talent for 2300+ companies in permanent as well as contractual roles spread across industry sectors from its 59 offices in 42 cities in India. We have multiple teams, each specialising in recruitment of talent across a wide range of skills and levels in sectors like Manufacturing, Energy, Infrastructure, IT & Outsourcing, Pharma, Financial Services, Consumer Products and Services. CIEL was listed among the Largest Staffing Companies in India No.1 in terms of Geo spread and at 14th place by revenue as per the report published in Feb 2021 by Staffing Industry Analyst (SIA).


We leverage technology to deliver a superior experience to the candidates who apply for a position open with one of our clients. Our team chooses a handful of best-matching candidates from the pool of available talent in the market based on the candidate's profile, skills and experience. These days, we recruit about 25000+ candidates a year and are growing this number every year.


We believe in finding talent from diverse backgrounds, striking a balance between the aspirations of our candidates with the requirements and thoughts of our clients while recruiting for them. CIEL won the Great Place to Work-Certification for the 2nd time in a row. Our team has remained passionate and committed to the core values of the company: Growth, Professionalism, Dignity and Diversity. CIEL is an ISO 9001:2015 certified company and committed to stakeholder satisfaction through continual improvements in its quality management system.


#GetTheBestOutofUs is its spirit.

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