18 Oct
Johnson & Johnson
Mumbai
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 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.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. 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 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.
▶️ Assistant Manager Commercial Quality
🖊️ Johnson & Johnson
📍 Mumbai