Title:  Officer

Education :  Master of Pharmacy

Experience: 5- 12 Years

Job Responsibilites: 

•  1 Authorized to sign as a Doer & as a checker in following documents :
• Risk assessment, process validation protocol, Incident and Investigation report, action, Compliance and closure.
• CAPA plans and closure, Protocols & reports.
• Internal Quality Audit Compliance and closure.
• Change control, Standard Operating Procedure, Planned Modification.
• Any other documents used for the execution of activities.
•  Participation in Investigations, Root cause analysis and proposing relevant CAPAs against OOS, OOT, incident, and change control, complaints and audit observations to QMS team.
•  Assure all time readiness department for regulatory agency inspections/internal audits and
• appropriate implementation of corrective actions regarding observations made by the agencies and internal audit teams.
• Responsible for ensuring market complaints, failures deviations are investigated and corrective  and preventive actions are implemented as per set timeline.   
•  Responsible for all the production documentation activity related to Manufacturing of Parenteral    production department.
• To check the maintenance of the department, premises and equipment in the area.
• To help and guide the officers into standardize production activities to achieve better efficiency and quality.  
• Any other responsibility assigned by department head after ensuring the relevant training status