Preparation of CTD files according to ICH guidelines.
Expertise proficiency with software tools and matrices for CTD submission.
Provide the regulatory reviews of customer complaints and defining the regulatory responsibility.
Conducting internal audit for production department, engineering, warehouse, etc..
Perform the intermediate and finished product and on-line inspections.
Regular check of RH (%), DP and temperature in different production areas.
Reporting any deviation happened in production area.
Handling of returned drug products.
Responsible for Annual product review data collection.
Coordinate / Support Change Controls as needed.
Write, review and approve Policies, Standard Operating Procedures (SOPs) and associated processes/guidelines.
Coordinate activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish notes and action items from meetings; provide support to the investigation process and follow-up to assure timely discrepancy closure.
Perform independent quality evaluation of deviation reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending.
-˙˙˙˙˙˙Ensure that inspection and audit responses are completed from initiation to closure-˙˙˙˙˙˙Support activities to evaluate regulatory compliance-˙˙˙˙˙˙SOP writing/revision
Participate in the internal audit program, vendor qualification audits,
Initiate, Review and approve deviations, CAPAs, change controls.
Revise and issuing the SOPs for all the departments
Check in-process testing done by production technicians by performing testing, reviewing test data, and writing investigations according to SOPs and GMPs.
