Quality Specialist

The Quality Specialist is a member of the KN Integrated Logistics Team and is responsible for the implementation and oversight of a quality management system in line with Pharma standards (GxP) to meet both internal and external customer specific requirements.

Your Role The position will report to the Business Manager of KN Integrated Logistics, with close working relationships across the business including the Logistics Partner Management, Performance Management and Business Analytics. Your Responsibilities

Responsible to establish procedures, quality standards and to monitor delivery against agreed targets by inspecting, recording, monitoring, controlling and reporting on all quality and business control matters.

• Achieve quality assurance operational objectives by monitoring and assigning day-to-day activities, identifying and addressing gaps and problems and providing regular feedback to customer and stakeholders regarding performance and issues.
• Ensure that a GxP quality system is implemented and maintained, according to the WHO GDP guidelines, latest version and the EU GDP guidelines, latest version.
• Ensure Good Document practices in regard to follow-up, store and archiving of GxP documentations.
• Pro- active information and follow- up of GDP changes and improvements.
• Act as a SPOC for the customer and LSPs for all quality related topics.
• Preparation and execution of regular customer/LSP meetings.
• Manage and monitor changes through Change Control Program.

• Compliance with required customer quality standards.

Audits

• Organize and perform internal audits.
• Organize and perform external audits in line with customer requirements.
• Organize and participate in customer audits.
• Distribution of audit reports and induction of subsequent corrective action plans and follow up of the corrective plans

Trainings

• Perform internal GxP trainings and permanently review and follow-up of training requirements.

Document Management

• Support development and implementation of WI's and SOP's using an advanced knowledge of GxP's and industry standards.
• Ensure regular update in line with industry standards.
• Maintain Technical Quality Agreement (TQA).

Non-Conformity Handling

• Approve, review, and follow-up of any deviations including but not limited to external logistical complaints with impact on product quality.
• Perform gap analysis and propose action plans to relevant stakeholders to close gaps with the aim to continually improve the performance of the NC handling and timeline.
• Report all NC and audit related deviations and ensure immediate action.
• Identify, implement and follow-up on CAPAs in close alignment with the LSP base and the customer.
• Assist in the development of pro-active strategies as preventive measures against potential future issues with systems or processes.

Your Skills and Experiences

• Quality and/or regulatory experience in a pharmaceutical and/or distribution environment.
• Work experience of at least 3 - 5 years.
• Strong affinity with required customer quality standards.
• Ability to communicate and negotiate on all levels, both internal and external.
• Good communication skill in  English and Hindi.
• Strong focus on customer + stakeholder relationships.

Good Reasons to Join As an employer, Kuehne+Nagel stands for equal opportunity and we are committed to diversity in our teams with regards to people with disabilities. We believe that you can make a valuable contribution to Kuehne+Nagel and look forward to receiving your application.