Job Description:
To review documentation of manufacturing and packaging.
Retrieve electronic scans and review batch records based on cGDP, cGMP, CPC’s SOPs, and FDA guidelines.
To perform batch data entry for APR and process validation.
Preparation of Annual Product Review / Product Quality Review reports.
To review the process validation report.
Education Qualifications:
B. Pharm or M.sc with 2-4 years of work experience in the FDA regulated / quality assurance industry.
Required Skills:
Ability to read and interpret FDA guidelines as they apply to documentation reviews.
Knowledge of cGMPs related to US FDA and EU EMEA manufacturing environments.,
Knowledge of manufacturing and packaging processes.
Proficiency in Microsoft Word, Excel, graphs/charts, and databases.
Ability to communicate effectively.
Ability to compile, organize and track documentation.
Detail-oriented, with excellent proofreading skills, and the ability to multi-task in a fast-paced workplace.