Quality, Regulatory, SHE & Compliance Specialist jobs in Roche in Al Kuwait – Kuwait

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To assure the fulfillment of all Roche divisional and local authority quality and regulatory requirements for Kuwait, providing support on any quality & regulatory matters required for commercial operations. To develop, establish, implement, report and follow up all the local initiatives and corporate guidelines regarding regulatory affairs, giving support to other areas/functions about these topics.
To provide legal advice, preparing legal documents, negotiating, remaining updated with legislation changes, proactively and efficiently engaging with stakeholders, working autonomously but also as a team player while maintaining at all times company s values, best interest and confidentiality.
Work closely with internal and external stakeholders to ensure SHE and Security compliant-relevant activities with 3PL, distributor and critical suppliers.
Your Responsibilities
Internal Quality
•Ensure compliance to Divisional guidelines and implementation of RDME Regional QMS, support Audit preparation and promote training and compliance within the country
•Accountable for timely execution of SBN and QN
•Coorinate and record quality compliant credit reimbursement with the Middle East Quality Team
•Oversight case governance :ensures that local performance on Complaint handling KPIs are met
•Identfy and report to Kuwait senior management on Laboratory Quality metrics , improvement opportunities
•Ensures that all procurement and supplier quality approvals and assessment are complaint to Roche Divisional standards ( DS38)
•Prepare Roche Diagnostics Kuwait for Quality audit
Supply Chain Quality
•To assure that the warehousing and distribution processes do not adversely affect the product quality and are in compliance with the applicable regulations, Roche Divisional Directives (mainly but not limited to DS39, DS01)
•Interface with local regulatory authority as quality representative and maintain relationships with regulatory authority
•Coordinate with local distributor and Middle East Quality Team in case of lot restrictions/quarantine/removal
•Coordinate and record logistic claims eligible for marine cargo insurance with the Middle East Quality Team
•Provide quality input and approval on the investigations related to internal deviations and/or customer complaints and temperature deviations
•Product return assessment and approval
•Ensure local Regulatory authority compliance for product importation and registration activities
•Estabishes a bilateral relationship with the regulatory authorities, acting as key liaison
•Ensure compliance and maintain awareness of global regulatory bodies requirements/inspection methods
•Ensuring PIPO process is aligned with the local Regulatory authority compliance
Local SHE Officer
•Ensure that all Roche Corporate SHE requirements are met within Roche Diagnostics Kuwait
•Coordinate with RDME SHE Manager to conduct Risk Assessments for office and field activities with the involvement of Line Managers
•Coordinate Local Emergency team for Roche Diagnostics Kuwait , collaborating with RDME SHE Manager for all Business disruptions and emergency plans
•Nominate and Train office Fire Wardens and First Aiders, ensuring adequate training
•Conduct Fire Evacuation Drills to test the Fire Plan Response capability of the organization
•Prepare lessons learnt from the fire evacuation drills and close the identified gaps in future drills
•Ensure completion of Hepatitis B Vaccination Program and update RDME SHE Manager on completion status
•Prepare SHE Training Matrix for Office, Field and Sales employees in consultation with RDME SHE Manager
•Prepare Roche Diagnostics Kuwait for SHE audit
•Ensure the adherence to Compliance standards and policies
•Ensur that all employees in Kuwait are aware that they can and should raise and discuss any compliance question with the line management or the compliance department in case they have doubts about the correct business behavior
•Ensure knowledge and best practice in Kuwait through sharing of common issues and problems
•Support the organization ensuring compliance with all applicable regulations, codes and guidelines
•Ensure compliance with the corporate policies, process and Quality System and recommend potential improvements to superiors
•Support the successful implementation of regional and local initiatives / projects
•Prepare Roche Diagnostics Kuwait for Compliance audit
Develop awareness towards Compliance
•Ensure that all employees in Kuwait are well trained and have a common understanding and knowledge of the Roche values as well as the Roche code of conduct
•Develop, deliver and oversee trainings relating to the Roche group code of conduct, company policies, business ethics, Roche s values and compliance initiatives with the goal to strengthen compliance awareness
It is expected that conduct is adhered to in regards to all applicable laws and regulations as well as to high integrity standards set forth by Roche.
Who You Are
•You hold a BSc degree in Life Science, Logistics, Business Administration, or any relevant education
•You have at least 3 to 5 years of work experience in a similar role
•You have knowledge and working experience in regulatory affairs in healthcare sector. Proven experience in preparing, performing, reporting and following on regulatory processes
•You re familiar with Roche Divisional Standards, Quality Management Systems and Complaint Management processes.
•You are fluent in English language (spoken and written). Arabic is considered a plus
•You have attention for detail
•You have advance organizational and time management skills
•You are flexible with the ability to thrive in a fast paced and changing environment
•You are a strong team player yet able to work independently
•You have strong communication skills
•You are customer focused, innovative, resourceful, and proactive
Roche is an equal opportunity employer.
Quality, Quality > Quality Assurance

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