1. Review compliance against 21 CFR Part 11requirements for electronic data generating systems. 2. Review SOPs, Checklists, Test procedures,Formats, Master batch records and Laboratory testing worksheets foridentification of complex procedures/formats. 3. Review controls on computerized systemsto ensure data generated from these systems is meeting the data reliabilityrequirements. Review paper data, electronic data and audit trail of GMPactivities at the site to check adherence and compliance level with respect todata reliability. 4. Perform walkthrough on the shop floor toidentify the complexities in the processes which may lead to deviation fromALCOA+, and to take CAPAs as needed. Provide training to employees on thedifferent topics related to data reliability and data security aspects. 5. Review several trends (but not limitedto) like GDP error, OOS, deviation and lab incident and identify CAPAs asappropriate to prevent the departure from ALCOA+. 6. Perform periodic surveys (related toALCOA+) from employees, analyze feedback received from survey, and to takeCAPAs as needed. Review of investigations related to data reliability at site. Qualification : M.Sc./M.Pharm. Experience / Exposure in. (2 points) : Musthave knowledge and experience in injectable plant. Candidates with QC backgroundwould be preferred.

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