Manager - QMS & QA

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 devices and solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, cartridges, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. Gerresheimer supports its customers with comprehensive services along the value chain and in addressing the growing demand for enhanced sustainability. With over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. The Group generated revenues of around €2bn in 2023 and currently employs around 13,400 people. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).   

• 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.

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

• 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 .