3 Month Assignment.
Prepare documentation to include specifications, method verification/validation reports, method transfer reports, and characterization reports as and when needed in appropriate format required by regulatory affairs.
Review, revise and draft Standard Operating Procedure documents.
Working efficiently to setup Active Pharmaceutical Ingredients (API) as well as Finished Product (FP) specification based on API manufacturers drug master file (DMF), United state Pharmacopeia (USP) monograph and ICH guidelines with the help of group leader and scientist.
· Interact with QC Scientists/ Tech Service Scientists to prepare and finalize the verification/validation protocols, reports and methods.
· Review the Operating Procedures and address the corrections to implement changes.
· Prepare analytical documents such as In-process and Finished Product Specifications, method validation and characterization reports.
· Revise applicable methods/specifications due to alternate API sources or excipient sources.
· Support and complete documentation required for any changes/improvements per functional/departmental requirements (change control, procedure updates, document changes, etc)
· Provide guidance to new hired employees for good documentation practice to harmonize with the system.
· Participate in technical discussion with scientists to identify root causes of technical issues.
· Work with scientists to prepare official documents for submission/usage on the floor.
· Prepare reports as it relates to FDA filings (PAS/CR/IR).
· Performs other functions as required or assigned.
· Complies with all company policies and standards.
· Bachelor’s Degree (BA/BS) required
· 3 years or more in Regulatory Affairs, Technical Writing, and/or Pharmaceutical industry.
· Effectively communicate problems and solutions applicable to analytical testing activities, thoroughness in record reviews, technical writing, scheduling to be able to meet commitments.
· Ability to adapt to changes in assignments flexibility, and meet department deadlines. Must have great follow-up skills.