About the Firm
The firm is more than 200 years of experience in producing the quality standards helping major bio-pharmaceutical firms in delivering high quality medicines to relieve many diseases. This is an organization supplying methods at free of cost for the product development and maintaining the standards. This is distributed across the globe serving mankind.
About the Job
Experience required 3-5 years
Qualification required: Candidate need to have masters degree in pharmaceutical or chemistry
Need to have handling of instruments like HPLC, UHPLC, LCMS, GCMS, ICP-OES, FTIR, UV visible,
Candid need to have understanding about the good laboratory practices regulations and external regulatory audits
Standard need to have good communication skills with diplomacy and enthusiasm
Candidate need to handle analytical method validations method developments by using the modern techniques and protocols
Roles
Candidate need to complete lifecycle of the monograph development, modernization project (initiation, execution, reporting, & completion).
Search relevant literature for the USP/NF monograph modernization projects and required to ensure the GLP & safety procedures while working in Lab.
Strong experience of method development and validations (DS/DP/Excipients) and worked on chromatography (HPLC, GC) techniques.
Responsible for design, review, and execution of method development experiments and perform method validation in accordance with laid down procedure.
Engage in project planning, execution, method development and validation according to set standards as USP general chapters, guidelines, SOPs and protocols.
Plan individually the project requirements and their completion within the timelines by coordinating with the supervisor and team.
Responsible for preparation of method validation protocols and reports and able to handle the for regular maintenance of assigned instruments.
Ensure that the calibrations of the equipment are performed as per the schedule.
Responsible for review of IQ/OQ/PQ documents of instruments.
Responsible for method development and validations (DS/DP/Excipients), using chromatography (HPLC, GC) techniques
Indent the required glass ware, chemicals, and columns for the CDL projects.