ASSISTANT MANAGER COMMERCIAL QUALITY

Job title.
Assistant Manager-Commercial Quality.
Reporting to.
Sr.
Manager-Commercial Quality.
Overall purpose of job.
Plan, execute and manage Quality assurance& quality systems activities to ensure compliance for GMP, GDP components, at applicable sites in JJMTI scope.
Support for maintaining compliance for Repack Relabel activities, QMS of distribution centers, Process & Product Inspection and Release, CAPA/Non-conformances, Complaint Management, Distributor Management, Document Control and Training Systems.
Establishes and maintains quality assurance programs, procedures, and controls for JJMTI Quality Management System.
Knowledge and understanding of MDR and D&C Act & Rules ’ Legal Metrology.
To provide necessary support for the activities performed at Repack Relabel sites and 3PL DC’s and ensure compliance as per regulatory and JJMTI QMS requirements.
To ensure the performance and quality of products & services confirms to established company and regulatory standards.
Effective use of the quality tools such as Windchill, EtQ, TruVault, SAP, SUMMIT etc as guided in the JJMTI QMS.
End to end supplier management– Ensure timely update of Approved Supplier List, to support for onboarding/disengagement of suppliers as per business need.
To monitor and plan the supplier audit as per schedule.
To monitor Internal audit plan, to ensure timely conduct of internal audit and tracking for timely closure of Internal audit observations.
To Execute / Support for supplier/distributor audits to ensure compliance organizations/ regulatory requirements and with international standards.
Organize, plan, lead and manage quality-related projects in alignment with Organization goals, as and when assigned.
Support for execution of MRM as per JJMTI QMS and to coordinate for required data for MRM.
To provide applicable data for Monthly reports/metrics.
To Handle product recall, field actions and stop shipment as per JJMTI QMS and regulatory requirements.
To coordinate with applicable stakeholder for execution and timely closure of stop shipment/ product recall.
To handle and coordinate for inspections and escalations as per JJMTI QMS.
Support activities related to document control, CAPA, NCR systems and processes.
Support with active participation in investigation of applicable reported issues, follow up the action plans and documentation.
Review of the investigation and recommendations for corrective action.
Facilitate 3rd Party audits, i.
.
Notified Body, FDA and other regulatory agency compliance inspections as well as Corporate audits and coordinate responses.
To track the status of open change request/notice and publish the report periodically.
Attend applicable training sessions as well as complete mandatory trainings in on-line Learning Management Systems (SUMMIT) and retain all training records.
Qualifications Required Qualification and Core Competencies for the role.
Bachelor’s&/ or master’s degree in science, Graduate in Biomedical Engineering or equivalent is required.
Must have at least years’ experience in Pharm/ medical device industry.
Quality systems implementation and maintenance of GMP/ Quality Systems Regulations; ISO , ISO at Distribution Centers.
Knowledge and competency in application of Local FDA (D&C act), ISO , ISO and other regulatory requirements especially in Quality Systems related to Repack Relabel activity and Distribution Center activities.
Excellent written and verbal communication/ presentation skills necessary to meet the needs of various audiences.
with a demonstrated track record of strong organizational and interpersonal skills.
Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint and Outlook.
Influencing and working well with others in a proactive, constructive manner, & communicating clearly, within all levels of the organization.
Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences with a demonstrated track record of strong organizational and interpersonal skills.
Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.