DUTIES AND RESPONSIBILITIES
Quality Assurance as per ISO 9001, CEIV TCR, TAPA and WHO/ EU GDP legislation (latest version) and/or local rules.
Ensuring compliance with national and international standards and legislation.
Promoting quality achievement and performance improvement throughout the organization.
Analyze various business statistics.
Review existing policies and develop new plans to improve the existing quality system.
Identifying relevant quality-related training needs and delivering training.
Working with product managers to establish quality requirements from external suppliers.
Agreeing standards and establishing clearly defined quality methods for staff to apply.
Conduct and execute internal &external audits within the organization, ensuring compliance to the guidelines, processes, and work instructions.
Evaluate, define, and implement CAPA’s where compliance is not given
Review and assess the effectiveness of changes made
Liaising with customers’ auditors and ensuring the execution of corrective action and compliance with customers’ specifications.
Effectively interact with Products and Development teams to assist introduce new products
Organize and manage quality assurance function in close co-operation with the customers and with the Company’s Management team (Member of Management Team).
Setting QA compliance objectives and ensuring that targets are achieved.
Leading independent quality reviews and/or liaising with relevant 3rd parties/ SMEs.
GDP compliance projects for stations, lanes, customers, suppliers - including project planning, design, analysis, execution, follow-up, re-audit, monitoring, hand-over
Support strategic development of Life Science in terms of “customer compliance needs”, compliance of our Global QMS System against GDP requirements
Support Life Science Leader and stakeholders for customer/supplier/stations meetings
Support resolution of global NCR’s, complaints, claims
Support design of global training concept for GDP
Considerable experience in quality assurance and supply chain solutions ideally in the Pharmaceutical sectors.
Execute all Dangerous Goods shipments in compliance with all applicable laws and regulations (as applicable).
Standard Responsibilities:
Contribute actively to a healthy and secure work environment by reporting unsafe/unsecure/unhealthy conditions and possible improvements.
Apply continuous improvement culture and attitude
Quality first thinking
Strong Team Player
Actively live and role-model our core values:
Earn our customers’ trust.
Value or teammates.
Engage in our communities.
Apply our ethics.
High Performance at a world class level.
QUALIFICATIONS AND REQUIREMENTS
3-5 years experience in Quality and/or international freight forwarding
Internal/external Auditor Training, GDP auditor
Well understanding of ISO standards and requirements
Proven track record in Customer Service related activities
Good experience in the transportation and/or supply chain solutions ideally in the Pharmaceutical sector
Demonstrated work experience in process implementation, customer service and logistics preferably in/for the Life science sector.
Ability to work independently and in a group environment