Gerresheimer

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"><html><body><section class="job-section" id="st-jobDescription"><div> <p class="googlejobs-paragraph--empty"/> <h2 class="title">Job Description</h2> </div> <div class="wysiwyg" itemprop="responsibilities"><ul> <li>Responsible for the implementation, update and improvement to the ISO 9001:2015 Quality Management System, ISO 15378: 2015, GMS, etc.</li> <li>Responsible for GMS, Quality Management Systems implementation, self-audits and working with other managers to coordinate initiatives to improve all KPI’s through GMS.</li> <li>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.</li> <li>Demonstrates behavior that meets Good Manufacturing Practices, Safety and Good Housekeeping requirements.</li> <li>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.</li> <li>To issue Quality Formats to relevant departments in controlled manner.</li> <li>For review the maintenance of all Equipments\Instruments involved in the Quality department.</li> <li>To review DQ/IQ/OQ/PQ and to monitor calibration/validation activities within the plant. (Process/Machine/Equipment/Instruments etc.)</li> <li>To arrange MRM and review all points discussed in MRM and to implement/monitor/follow up same into relevant area.</li> <li>For Quality Checks of incoming RM/PM as per its Specifications and submit the report to relevant department.</li> <li>To prepare Batch Records and to Release batch in consultation with Production Manager,  QC Manager and Plant Manager.</li> <li>To check Cleaning, Safety Precaution and Hygiene requirement as per quality procedure within the plant.</li> <li>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.</li> <li>Participates in cross facility audits as a Lead Auditor or Assistant Auditor.</li> <li>Coordinates all sample submissions of new products and initiates change control policies.</li> <li>Coordinates investigation for all customer complaints.</li> <li>Ensures that all non-conforming material, either raw material or finished goods, is handled according to established policies and procedures.</li> <li>Formulates and maintains Quality objectives and coordinates those objectives in cooperation with other managers to maximize quality, reliability and to minimize costs.</li> <li>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.</li> <li>Consults with all segments of management responsible for plant policies.</li> <li>In absence of Quality Head he is responsible for batch release process.</li> <li>Maintain all Quality Management System documentation.</li> <li>Arrange Internal Quality Audit within all departments.</li> <li>Review Quality Management System & GMS Documentation and Records on daily basis.</li> <li>Follow up of audit Nonconformance’s and responsible for clearance of Nonconformance’s well within time.</li> <li>Review Customer Complaint in consultation with Production/QC and to find out Route Cause for it, to take Corrective Action and Preventive Action accordingly.</li> <li>Implematation of verious management systems with in the organization.</li> </ul></div></section><section class="job-section" id="st-qualifications"><div> <p class="googlejobs-paragraph--empty"/> <h2 class="title">Qualifications</h2> </div> <div class="wysiwyg" itemprop="qualifications"><p>Bachelor of Engineering / Master of Engineering / Bachelor of Science / Master of Science and similar qualifications</p></div></section><section class="job-section" id="st-additionalInformation"><div> <p class="googlejobs-paragraph--empty"/> <h2 class="title">Additional Information</h2> </div> <div class="wysiwyg" itemprop="incentives"> <p> </p> <ul> <li>Strong exposure to end-to-end Quality Assurance functions including internal & External Audit, CAPA, SOP, GMS, ISO Certification..</li> <li>Prior experience in MNC organizations is preferred.</li> <li>Experience in the <strong>Glass (Tubular) industry</strong> is advantacge.</li> <li>Minimum 10 Years of Experience in Pharmaceutical packaging industries or Pharmaceutical industries .</li> </ul> </div></section><section class="job-section margin--bottom--xl" id="st-embed-map"><h2 class="title">Job Location</h2> <div> <iframe title="Job Location" role="application" aria-hidden="true" tabindex="-1" height="200" frameborder="0" 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