Quality Assurance Manager

The MM (MAYR MELNHOF) Group (MM) is a leading global producer of paperboard and folding boxes with an attractive range of kraft paper and uncoated fine paper for various end uses. MM promotes sustainable development through innovative, recyclable packaging and paper products operating across 72 production sites on 3 continents. MM Pharma & Healthcare Packaging division specializes in the manufacturing of secondary packaging for the pharmaceutical and healthcare industries. Customers are global pharmaceutical companies who are partnered with offering customized packaging solutions based on many years of experience and extensive market know-how. With a comprehensive range of services from the conception to the production of folding boxes, labels, leaflets (package inserts) and wedging systems to the implementation of complete packaging lines and co-packing, the highest product safety is guaranteed utilizing market leading technologies. #growingtogether for the future of MM and our customers! Job Description Responsible for all Regulatory, Quality Control and Assurance activities at Site level. Has critical decision-making authority in Quality product release for Sale or Supply. Has overall responsibility for quality decisions and liaison with external parties on matters that relate to the Quality Management System. Continuously improve the end-to-end customer quality experience by ensuring customer quality needs and expectations are met and exceeded in a consistent, joined-up, audit-ready manner across the site. Own customer audit readiness at site level, including preparation, hosting, evidence coordination, response management, CAPA commitments, and timely closure of customer audit findings. Continually drive site improvements in quality performance through the capture of data internally and externally, analyzing and spotting trends, issues and opportunities and ensuring these are proactively acted upon. Leads the local Quality team and will carry the responsibility of ensuring that the day-to-day Quality function is consistently executed. Ensures Management Systems are established, documented, and continually improved across the site and are in line with Pharma & Healthcare Div. Policies and Guidelines to effect consistent execution. Together with Site Leadership team, drive a culture of Quality to ensure that Quality is “built into” rather than “inspected into” the Production and Supply Chain Operation. Typical Accountabilities The Quality Manager will manage and be accountable for the Quality unit. In this capacity they will oversee: Customer Quality Customer Complaint Management: timely logging, effective investigation of the root cause(s) to prevent reoccurrence and responding to /closing of such complaints in line with customer requirements. Identify opportunities for improvement initiatives with key customer accounts, because of Customer Satisfaction Surveys and other customer feedback. Provides a single point of contact regarding quality agreements with customer accounts supplied. Effectively implements customer AQLs and Technical/Quality Agreements across the site, ensuring customer quality needs, audit expectations, and contractual requirements are understood and consistently met throughout the Production and Supply Chain Operation. Consolidates, monitors and analyses site quality data / dashboards for designated customers. Represents the site in customer quality reviews, audit meetings, complaint escalations, and quality performance discussions, ensuring accurate communication and timely follow-up. Manufacturing Quality The day to day completion of batch QC testing and product release in line with the production plan and dispatch schedules as necessary to ensure compliance with customer requirements. Approval or rejection of all raw materials, components, in-process materials, product, and labelling. Review of production records to ensure no errors have occurred and, if errors have occurred, that they have been fully investigated and satisfactorily resolved. Approval or rejection of products manufactured, processed, packed, or held under contract by another organization. Review and approval of reprocessing and reworking. Regular cycle of internal Site Quality reporting, ensuring data is timely and accurate, providing analysis and insights to support executive decision making. The day to day administration of the calibration systems including the maintenance of the calibration schedule, the management of calibrations and frequency, investigation into calibration failures and the management of calibration records. Facilitates the Change Control process at site level ensuring successful outcome, including raising and approving change requests, completing change impact assessments, tracking, monitoring, and reporting on change progress. Facilitates, reviews, and approves deviation investigations and root cause analyses conducted at site level for both internal and external deviations, including risk assessment, systematic CAPA capture, implementation, and effectiveness verification. Review, assess and approve / qualify critical local suppliers. Verifies the accuracy of certificates from third parties. Consolidates, monitors and analyses Site quality data / dashboards for designated site suppliers including supplier score cards on local basis. Ensures risk-based supplier oversight, including supplier qualification, supplier audit support, quality agreement follow-up, supplier CAPA management, and escalation of supplier performance risks. New Product Introduction As / when required, ensures appropriate standards are followed relating to innovation, design and new manufacturing equipment and new product introductions. Prepares validation documentation in line with company, customer, and industry expectations. Approves validation, verification, and qualification documents. Supports the validation execution of new and existing equipment according to schedules and industry best practice. Where applicable, presents the findings and explain the rationale for changes required to ensure effective manufacturing and product quality. Supports the central and local teams during the innovation or development of new products. Management Systems Maintains the Electronic Quality Management system (EQMS) Entropy, ensuring the data it contains is accurate and up to date. Effectively logs, manages and monitors CAPA (Corrective Action Preventive Action) from internal and external Audits/NCRs within the EQMS. Supports the effective delivery of internal audits and customer-audit readiness activities to ensure compliance with standard requirements in design and manufacturing processes, including GMP, ISO 9001:2015, PS9000, FSC, BRCGS Packaging, customer quality agreements, MM policies, and strategic objectives. Approves or rejects all written procedures or changes to those procedures, for production and process control(s) designed to assure product quality and integrity. Approves or rejects any deviations from the documented procedures. Approves or rejects specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms as well as changes to these documents. Plans and maintains refresher GMP and Management Systems trainings which include areas such as changes to processes and procedures as well as changes to roles or responsibilities. Promotes data integrity, documentation discipline, and controlled record management to ensure records are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available when required. People Manages and develops Site Quality team. Supports the development of the site quality team through mentoring, formal training, project / work experience, and knowledge sharing. Keeps the Team motivated to secure optimum performance and commitment in short and long terms. Assists with departmental training and completion of training documentation. Develops, maintains and delivers GMP induction training to new site personnel appropriate to their duties and responsibilities assigned. Education and Qualifications Bachelor Degree in Science/Engineering or equivalent industry experience. Internal Auditor certification in applicable Standards and Systems. ISO 9001:2015 or BRCGS Packaging Lead Auditor certification. Skills and Experience 3 years’ experience in a Quality Management function role within manufacturing (or equivalent) environment. Experience in the Print and Packaging Industry Experience preparing for, hosting, responding to, and closing customer, certification, or regulatory audits in a regulated manufacturing environment. Demonstrable track record of delivering improvements in quality management, audit readiness, CAPA effectiveness, and customer quality performance. Experience in or supply to the Pharma and Healthcare industry. #J-18808-Ljbffr