Education : Master of PharmacyExperience: 5- 12 YearsJob 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