JOB Description

Department: Quality Assurance

Position: Sr. Manager / Head

Job Role:
- Preparation review of departmental Standard Operating procedure, Work Instructions and forms.
- Provide training to personnel on SOPs, work Institution, forms GMP and GDP compliance.
- Perform review and organize the qualification activities for the contract manufacturing organization, contract Testing Laboratory as per regulatory requirements to ensure GMP and GDP compliance.
- Monitoring and reporting on the effectiveness of the Quality management system within the organizations and at outsourced service providers.
- Initiation and Review of change control, Deviation and complaints as per requirement.
- Responsible for closing the QMS actions.
- Circulating and monitoring the QMS Dashboard activities.
- Review quality technical agreements with outsourced service providers.
- Assist the Qualified Auditors in performing audits at service providers facility.
- Monitor performance and help identity improvement and effectiveness of the Quality activities.
- Perform,



review and organize supplier qualification activities for the Active Pharmaceutical Ingredients, excipients and packaging materials as per regulatory requirements to ensure GMP and GDP compliance.
- Creating, performing the software validation activities and related documentation.
- To carry out the assignments assigned by the Director and management.
- Manage and maintain an effective Quality Assurance program for the organization in alignment with Global Operating Procedures.
- Ensure Vendor qualifications done at CMO/In-house.
- Discussion with CMO regarding compliance issues.
- Review operating procedures to ensure compliance with all related procedures, instructions and the Quality Manual.
- Provide guidance to the team in the development, implementation, monitoring and review of QA procedures.
- Establish procedures and methods to comply with applicable EU GMP & USFDA, ISO requirements and customer expectations.

📌 Sr. Manager (Vadodara)
🏢 Novumgen
📍 Vadodara