This position ensures best practices for a compliant product and service to meet customer expectations and business requirements.
Responsibilities
· Responsible for providing leadership and management of the local quality program, quality policies and compliance processes to the internal organization and the quality team
· Ensure company quality strategies, policies and procedures are communicated, applied and enforced
· Perform various activities to facilitate compliance with GDP / GMP practices, Standard Operating Procedures and ISO 9001& 14001
· Implement, Maintain and manage an efficient Quality system, such as Procedures, Processes, Technical Agreements, Validation and Qualifications, Quality Systems, CAPA, Supplier Management, Internal and External Audits etc.
· Identify relevant GDP / GMP and quality-related training needs and deliver strategies, training and activities where required in cooperation with HR Department and external partners
· In conjunction with the line manager, set quality assurance objectives and ensure targets are achieved through effective quality performance monitoring, measurement, analysis and reporting
· Effectively interact with all stakeholders to maintain quality and help introduce new quality objectives
· In consort with the internal stakeholders, support, prepare, host, oversee and follow up on customer audits and regulatory inspections
· Provide compliance support to internal departments in managing their operation and commercial activities in compliance with quality systems requirements and GDP / GMP
· Maintain professional knowledge of relevant and current regulatory requirements and provide business intelligence in reference to new developments
· Lead and manage new customer implementations and projects from GDP/ GMP perspective
· Guide, manage and develop the local Quality team and liaise closely with the regional director on strategic decisions
Qualifications
· Previous experience in QA Engineer positions in an international environment in the pharmaceutical supply chain & Manufacturing (desirable)
· Minimum of 3 years relevant pharmaceutical industry experience in a managerial position in supply chain and/or manufacturing for the healthcare industry
· Excellent knowledge of domestic and/or international pharmaceutical and healthcare supply chain needs
· Accredited auditor of Quality Management Systems (desirable)
· Experience with hosting regulatory and client audits
· Experience with reviewing/approving Quality / Technical Agreements
· Management of Quality Systems in compliance with GDP / GMP requirements
· Experience with implementation/management of secondary packing operations (desirable)
Job Type: Full-time
Salary: ﷼5,500.00 – ﷼7,500.00 per month
Ability to commute/relocate:
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