16 Oct
J&J Family of Companies
Maharashtra
Assistant Manager Commercial Quality - 2406217874W
Description
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 2017and D&C; Act 1940 & Rules 1945 Legal Metrology.
- To provide necessary support for the activities performed at Repack Relabel sites and 3PL DCs 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.e. 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:
- Bachelors &/ or masters degree in science, Graduate in Biomedical Engineering or equivalent is required.
- Must have at least 10 11 years experience in Pharm/ medical device industry.
- Quality systems implementation and maintenance of GMP/ Quality Systems Regulations; ISO 13485, ISO 9001 at Distribution Centers.
- Knowledge and competency in application of Local FDA (D&C; act), ISO 13485, ISO 9001 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.
Primary Location Asia Pacific-India-Maharashtra-Mumbai
Organization Johnson & Johnson Private Limited (8080)
Job Function Customer/Commercial Quality
Req ID: 2406217874W
▶️ Assistant Manager Commercial Quality
🖊️ J&J Family of Companies
📍 Maharashtra