Vacancies at Roche

This role requires an individual that has experience with export compliance and regulatory topics as well as strong organisational and attention to detail skills.

• Manages and responsible for the trade compliance and export licences for transportation of goods. Includes interface with regulatory body and managing internal and external  audits and self-assessments. 
• Ensures legal compliance and provides import/export administration and control within government rules and regulations, including appropriate licensing for shipments.
• Drafting timely export licences, technical assistance agreements, and other forms of export licensing requests for submission to regulatory agencies.
• Support in the assignment of classification of goods in the tares customs tariff in accordance with the general provisions of the harmonised system.
• Creating and maintaining written procedures and guidelines for export control and customs compliance requirements.
• Develop and implement strategies to optimise import/export operations. (i.e optimisation of the animal content g-sheet, shipping request form, SAP reports etc.)
• Interfaces with internal and external customers, foreign order administration, freight forwarders, customs officers and other functional areas to ensure coordination and logistics of export shipments. Also including new product development projects and opportunities.
• Reviewing and developing company export/import compliance policies, procedures and programs for Roche Dia Cape Town. 
• Works independently within these guidelines and policies, and receives minimal guidance. Acts as a resource for colleagues with less experience and provides functional guidance.
• Maintain effective relationships with key internal and external stakeholders to ensure that export control is managed effectively and efficiently. The successful candidate will ensure that they hold regular meetings with the operations, research, development and procurement teams to ensure export requirements are in place and met.
• Communicating and corresponding, as the single point of contact, with the Department of Agriculture SA and hosting periodic Visits. This to support renewal and compliance to export licences.
• Provide advice to Management regarding changes and updates to Export Control Regulations and detail the business impacts.
• Other duties as assigned by management.

Who you Are as an Ideal Candidate

Qualifications and Education Requirements

• Bachelor's degree or equivalent combination of education and work experience
• 2-5 Years Proven experience within a Trade Compliance / Export Compliance role
• Effective troubleshooting and resolving difficult problems in creative ways. 
• Strong organisational and attention to detail skills.
• Able to take new perspectives on existing solutions, exploring and implementing new concepts and methodologies.
• Good written and verbal communication skills.
• Accountability, flexibility and strong work ethic.
• Ability to identify and communicate issues proactively
• Thorough working knowledge of relevant international ISO Standards (13485) and regulations (European medical devices directives) would be advantageous.

Preferred Skills

• Understanding of UK & US export regulations with be advantageous
• Proficiency in use of ERP software (preferably SAP).
• Knowledge of Lean concepts and applications.

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Key Challenges 

• Responsible for the day to day coordination and administrative tasks around ad hoc order management, fulfillment and manufacturing including but not limited to KX unit determination, tracking of Purchase Order details, material reservation, packaging availability, vet certificates, quality memo’s and communication with Hubs and affiliates/stakeholders involved as required. 
• Operations contributor for Custom projects here specific evaluation, input and experience is needed from Operations.
• For specifically ad hoc material requests: Integrate and collect feedback from departmental Single point of contacts to ensure product flow through order management, planning, manufacturing, QC and delivery to meet the turnaround objectives and commitments. Serves as the link between planning and order management e.g material reservations and shipping requirements.
• Works closely and aligns with Production Planners, team leads and/or supervisors on any unique or special customer requests.
• Executes and ensures completion of product documentation requests for quality, regulatory and registration for Customers. Cross functional collaboration with quality, research and development and manufacturing and commercial. 
• Proactively monitor and report on ad hoc material supply status, escalate and mitigate any issues or delays, ensures alignment on new delivery expectations. 
• Draft, executes and completes Custom Product Specification (CPS) for Cat A/B - all operational sections. Packaging requirements, stability requirements, QC requirements, feasibility, labeling, CoA requirements and SMC’s. Manages review of CPS with stakeholders and updates internal shared sheets. Reviews and approves workflows. Update to procedures and relevant documentation to reflect new Customer requirements (e.g. labels).
• Involved in internal process improvements, internal/customer audits/questionnaires (if and when applicable) and the custom supply squad to prioritize meeting ever changing customer requirements.
• Accountable for (compliance related queries and investigations from Customers/Commercial) CR’s, NCR’s and other queries or inquiries from commercial and the Business team. 
• Operations Custom squad member, supporting team address custom business activities/tasks, KPI’s and goals to support custom product portfolio growth and improvements.
• Responsible for drafting, updating Custom related procedures (e.g. SOP's, WI’s) to align with best practices and continuous improvement implementation.
• Support Production Planning activities as needed or assigned.

Who you Are as an Ideal Candidate

Qualifications and Education Requirements

• Bachelor’s degree in Science (Biology, Life Sciences or similar) or Business (Logistics, Operations, Supply Chain, Project Management)
• 5+ years Pharma or Diagnostics Industry/relevant industry experience

Preferred Skills

• Demonstrated interpersonal skills to work effectively with  cross-functional, cross-enterprise, cross-cultural teams in multiple locations.
• Good communication skills.
• Understanding of Operations, Manufacturing, Logistics and Supply Chain.
• Thorough working knowledge of relevant international ISO Standards (13485, 14971) and regulations (European medical devices directives) would be advantageous.
• Advanced understanding of ERP system knowledge especially SAP (preferred).
• Foresight and ability to be innovative and find creative solutions to problems. 
• Demonstrated ability to perform multiple, fast-paced tasks
• Demonstrated ability to prioritize and perform workload effectively, with minimal supervision.
• Continuous improvement mindset.