Manager, Commercial Quality

Abiomed

12 - 14 years

9 - 13 Lacs

mumbai

Posted:14 hours ago| Platform:

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Skills Required

product quality manager quality assurance pharma metrology healthcare manager quality control continuous improvement operations monitoring auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Establishes and maintains quality assurance programs, procedures, and controls for various elements of JJMTI
Quality Management system.
Knowledge and understanding of MDR2017 and D&C Act 1940 & Rules 1945 Legal Metrology.
Management of Deliver (3 PL-Warehouse and Distribution) and Service & Repair activities from QMS perspective.
Assist and Lead in Projects which will impact the Quality Management system of JJMTI.
Ensures that performance and quality of products / services conform to established company and regulatory standards.
Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems.
Formulates and maintains quality assurance objectives and coordinates objectives with procedures in cooperation with other managers to assure product quality & safety.
Support in the Supplier Management and monitoring and suggest improvement and ensure compliance to the Quality requirements.
Reviews reports findings and makes recommendations for corrective action/preventive action/effectiveness checks.
Understand and implement the Training requirements of the cross functional team members (including Commercial Quality) for performing expected tasks.
Monitor and Collate metrics and update on the applicable platform in a timely manner and ensure consolidation of data for MRM s.
Facilitate 3rd Party audits, i.e. Notified Body, FDA and other regulatory agency compliance inspections, internal and supplier s audits as well as Corporate audits and coordinate responses.
Escalate all significant quality issues as and when made aware of.
Attend applicable training sessions as well as complete mandatory trainings on-line e-University /Learning
Management Systems and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines.

Required Qualification and Core Competencies for the role:

Required Qualification-
Science Postgraduate, Bio Medical Engineer, Specialization in Quality Assurance Programs would be added advantage.
12-14 Years of experience in Pharma / Medical Device industry.
ISO lead auditor certification (QMS), ASQ Quality Auditor certification though not a requirement, would be an added advantage
FDA Approval preferred.
Ensure compliance of JJMI procedures to the Global Procedures and requirements and execute action based on the identified gap and create awareness on the QMS requirements amongst different stakeholders.
Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware.
Attend applicable training sessions as well as complete mandatory on-line trainings and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines.
Report any evidence of product tampering, diversion and counterfeiting to the Brand Integrity function. -Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner.
Travelling requirement to 3 PL W&D sites, Service center as applicable).

Required Skills:

Preferred Skills:

Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

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