Manager - QMS & QA

Company Description

• 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 KPI’s 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 Equipments\Instruments 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 Nonconformance’s and responsible for clearance of Nonconformance’s 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

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 .