CIEL/SEL/23441: Analytical Research and Development in API Industry – Hyderabad

  Regulatory Affairs

Job title: CIEL/SEL/23441: Analytical Research and Development in API Industry – Hyderabad

Company: CIEL HR Services

Job description: 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

Expected salary:

Location: Hyderabad, Telangana

Job date: Fri, 04 Feb 2022 07:53:59 GMT

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