Assistant Manager Commercial Quality

Posted: Wednesday, 16 October 2024
Valid Thru: Friday, 15 November 2024
Index Requested on: 10/16/2024 13:29:07
Indexed on: 10/16/2024 13:29:07

Location: Mumbai, MH, , IN

Industry: Advertising and Public Relations
Occupational Category: 13-0000.00 - Business and Financial Operations
Type of Employment: FULL_TIME

Johnson and Johnson is hiring!

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 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.

Responsibilities:

Please review the job description.

Educational requirements:

  • high school

Desired Skills:

Please see the job description for required or recommended skills.

Benefits:

Please see the job description for benefits.

Apply Now