Manager QMS & QA

Surat - India

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Department:

Quality Management

Job Summary

Responsible for the implementation update and improvement to the ISO 9001:2015 Quality Management System ISO 15378: 2015 GMS etc.
Responsible for GMS Quality Management Systems implementation self-audits and working with other managers to coordinate initiatives to improve all KPIs through GMS.
Responsible for identifying and coordinating all cGMP activities and ensure that the facility complies with established procedures and implements improvement to meet changing customer expectations.
Demonstrates behavior that meets Good Manufacturing Practices Safety and Good Housekeeping requirements.
For review testing of Raw Materials like Tubes Chemical for treatment etc. & packing materials like trays boxes wrapper etc. And to inform relative department about its status whether tests result complies or not.
To issue Quality Formats to relevant departments in controlled manner.
For review the maintenance of all EquipmentsInstruments involved in the Quality department.
To review DQ/IQ/OQ/PQ and to monitor calibration/validation activities within the plant. (Process/Machine/Equipment/Instruments etc.)
To arrange MRM and review all points discussed in MRM and to implement/monitor/follow up same into relevant area.
For Quality Checks of incoming RM/PM as per its Specifications and submit the report to relevant department.
To prepare Batch Records and to Release batch in consultation with Production Manager QC Manager and Plant Manager.
To check Cleaning Safety Precaution and Hygiene requirement as per quality procedure within the plant.
Revises and updates the Quality Systems Manual to ensure the program continues to be suitable and effective so the final product meets established and changing quality standards.
Participates in cross facility audits as a Lead Auditor or Assistant Auditor.
Coordinates all sample submissions of new products and initiates change control policies.
Coordinates investigation for all customer complaints.
Ensures that all non-conforming material either raw material or finished goods is handled according to established policies and procedures.
Formulates and maintains Quality objectives and coordinates those objectives in cooperation with other managers to maximize quality reliability and to minimize costs.
Maintains communications within area of responsibility as to the department goals and objectives customer issues results of capability studies and plans of actions and progress.
Consults with all segments of management responsible for plant policies.
In absence of Quality Head he is responsible for batch release process.
Maintain all Quality Management System documentation.
Arrange Internal Quality Audit within all departments.
Review Quality Management System & GMS Documentation and Records on daily basis.
Follow up of audit Nonconformances and responsible for clearance of Nonconformances well within time.
Review Customer Complaint in consultation with Production/QC and to find out Route Cause for it to take Corrective Action and Preventive Action accordingly.
Implematation of verious management systems with in the organization.

Qualifications :

Bachelor of Engineering / Master of Engineering / Bachelor of Science / Master of Science and similar qualifications

Additional Information :

Strong exposure to end-to-end Quality Assurance functions including internal & External Audit CAPA SOP GMS ISO Certification..
Prior experience in MNC organizations is preferred.
Experience in the Glass (Tubular) industry is advantacge.
Minimum 10 Years of Experience in Pharmaceutical packaging industries or Pharmaceutical industries .

Remote Work :

Employment Type :

Full-time

Responsible for the implementation update and improvement to the ISO 9001:2015 Quality Management System ISO 15378: 2015 GMS etc.Responsible for GMS Quality Management Systems implementation self-audits and working with other managers to coordinate initiatives to improve all KPIs through GMS.Respons...

Responsible for the implementation update and improvement to the ISO 9001:2015 Quality Management System ISO 15378: 2015 GMS etc.
Responsible for GMS Quality Management Systems implementation self-audits and working with other managers to coordinate initiatives to improve all KPIs through GMS.
Responsible for identifying and coordinating all cGMP activities and ensure that the facility complies with established procedures and implements improvement to meet changing customer expectations.
Demonstrates behavior that meets Good Manufacturing Practices Safety and Good Housekeeping requirements.
For review testing of Raw Materials like Tubes Chemical for treatment etc. & packing materials like trays boxes wrapper etc. And to inform relative department about its status whether tests result complies or not.
To issue Quality Formats to relevant departments in controlled manner.
For review the maintenance of all EquipmentsInstruments involved in the Quality department.
To review DQ/IQ/OQ/PQ and to monitor calibration/validation activities within the plant. (Process/Machine/Equipment/Instruments etc.)
To arrange MRM and review all points discussed in MRM and to implement/monitor/follow up same into relevant area.
For Quality Checks of incoming RM/PM as per its Specifications and submit the report to relevant department.
To prepare Batch Records and to Release batch in consultation with Production Manager QC Manager and Plant Manager.
To check Cleaning Safety Precaution and Hygiene requirement as per quality procedure within the plant.
Revises and updates the Quality Systems Manual to ensure the program continues to be suitable and effective so the final product meets established and changing quality standards.
Participates in cross facility audits as a Lead Auditor or Assistant Auditor.
Coordinates all sample submissions of new products and initiates change control policies.
Coordinates investigation for all customer complaints.
Ensures that all non-conforming material either raw material or finished goods is handled according to established policies and procedures.
Formulates and maintains Quality objectives and coordinates those objectives in cooperation with other managers to maximize quality reliability and to minimize costs.
Maintains communications within area of responsibility as to the department goals and objectives customer issues results of capability studies and plans of actions and progress.
Consults with all segments of management responsible for plant policies.
In absence of Quality Head he is responsible for batch release process.
Maintain all Quality Management System documentation.
Arrange Internal Quality Audit within all departments.
Review Quality Management System & GMS Documentation and Records on daily basis.
Follow up of audit Nonconformances and responsible for clearance of Nonconformances well within time.
Review Customer Complaint in consultation with Production/QC and to find out Route Cause for it to take Corrective Action and Preventive Action accordingly.
Implematation of verious management systems with in the organization.

Qualifications :

Bachelor of Engineering / Master of Engineering / Bachelor of Science / Master of Science and similar qualifications

Additional Information :

Strong exposure to end-to-end Quality Assurance functions including internal & External Audit CAPA SOP GMS ISO Certification..
Prior experience in MNC organizations is preferred.
Experience in the Glass (Tubular) industry is advantacge.
Minimum 10 Years of Experience in Pharmaceutical packaging industries or Pharmaceutical industries .

Remote Work :

Employment Type :

Full-time

Key Skills

Quality Assurance
FDA Regulations
Food Industry
Food Safety Experience
ISO 9001
Quality Systems
Food Processing
Quality Control
Quality Management
QA/QC
Selenium
HACCP

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About Company

Gerresheimer

Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The Group offers a comprehensive portfolio of drug containment solutions including closures and accessories, as well as drug delivery systems, medical dev ... View more

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