We are offering a challenging National Pharma & Compliance Manager function to support all Quality Management Activities for the BeLux Pharma and Healthcare business.
You will be responsible for the design and maintenance of quality programs, including but not limited to QA plans, inspection procedures, work instructions, training, deviation investigations, and RC / CAPA management, facility mapping, and validation projects meeting applicable regulatory requirements in close relationship to the sites local Quality Management and nominated RP’s.
The National Pharma & Compliance Manager must have a clear understanding of WHO GMP / GDP / GSP EU GDP and country regulations regarding the distribution and storage of pharmaceutical products, country Healthcare regulatory requirements, and country regulatory requirements for controlled substances storage & distribution practices.
Your Responsibilities Implement and maintain company Quality Pharma & Healthcare Management Systems with support of local QSHE and Operations and Site Management.
Provide quality expertise and leadership to management, QSHE / Sales, and operational personnel and clients.Interact both internally with company personnel and externally with clients / regulatory bodies.
Actively assure operational observance to compliance obligations to include, regulatory, contractual, and SOP driven requirements.
Look for ways to improve quality processes and procedures. Develop plans to evaluate Cost-of-Quality improvement projects.
Continually seek to identify opportunities to reduce customer costs.Create and implement Quality (Self-) Inspection plans with the alignment of National QSHE Management, manage quality process audits ensuring that self-inspections are performed at appropriate regular intervals and that areas for improvement are identified and addressed through KN Advantics.
Being an official nominated and trained KN Pharma Chain Auditor and actively perform national Pharma & Healthcare audit and if appropriate in other EUR KN Pharma & HC Stations.
Establish process metrics, and in-line and end-of-line process controls to ensure quality objectives are met.Develop and Implement on National basis training programs together with HR, as required, to ensure quality objectives are met and to continually improve results.
Develop and maintain interactions with client Quality counterparts; actively understand and manage client Quality expectations and share with Sales / Development / QSHE / RP.
Proactively communicate with client QA counterparts and management concerning quality issues, improvement plans, and status.
Investigate deviations and quality issues performing thorough Root Cause analysis and applying PDCA principles to the CAPA process with local QSHE or / and RP.
Control with local RP’s or QM Management accurate review and disposition of non-conforming products including management of product damage, expiry, quarantine, hold, returned goods, and recalls, ensuring that all relevant data is documented and communicated to clients.
Inform and prepare site personnel and RP regarding regulatory inspection readiness and act as the P.O.C. (point of contact) during inspections (if not covered by local RP).
Represent Kuehne + Nagel from a Quality Pharma & Healthcare perspective at client Quarterly Business Reviews.Function as an advocate for the client within Kuehne + Nagel.
Provide support to Sales in responding to RFP’s. High-level involvement in the business development process as it relates to Quality (tender analysis, solution design, costing, and service offering).
Your Skills and Experiences A university degree in Logistics, Business Management, Industrial Engineering or equivalent combination of education and experience.
Minimum or 5 years’ prior experience in similar positionPrior experience working in pharma / healthcare regulated environment required ( WHO GMP / GDP / GSP, EU GDP) Significant experience with implementation, maintenance of Quality Management Systems (ISO 9001, possible ISO 13485)Experience with auditing of Quality SystemsExperience with validations and qualifications required (systems, processes, facilities)Good communication skills, both verbal and writtenStrong proficiency with MS Office (Word / Excel / PowerPoint / Outlook)Very organized / MethodicalCritical / Analytic / ObjectiveAbility to work effectively in a high-pressure environmentAbility to effectively handle multiple, simultaneoustasks.
Good Reasons to Join We offer an employee friendly and casual environment for you to become a skilled transportation logistics professional in a challenging and fast developing company with a competitive salary and opportunities for further development within the Kuehne + Nagel Group.
Job SummaryJob number : req64907Date posted : 2020-09-23Profession : Freight Logistics & Customer ServiceEmployment type : Permanent