QARA Support at Alere Inc.

Job Description

Job Function:

• Supports the maintenance and effectiveness of ISO Quality management system of the Affiliate
• Implements Alere's Quality management and quality improvement programs as required in the designated territory/ distributors. Monitors and provides assistance with quality assurance and compliance functions .
• Assists in the Coordination and compliance of regulatory processes, license renewals, and product registrations to ensure the compliance of regulations for IVDs and medical Devices in the designated territory

Major Duties

• Assists in the Maintenance of the Alere SA Quality Management System to ensure it meets regulatory compliance as well as ISO / Alere Global Quality System requirements.
• Responsible for the implementation of Alere Global Quality Procedures applicable to the region and maintained in accordance to procedure.
• Implements the Distributor Compliance Program in the assigned territory to assure:
•  the on boarding of new distributors for the territory are assessed for Quality System Requirements
•  performs Audit on Distributors on contractual Quality System obligations and risk areas as per Audit program, that impact Regulatory and Quality compliance of Alere products.
•  Performs Audits as defined by the Alere SA QMS Audit programmes and audits are performed in accordance with said procedures.
•  Develop, recommend and monitor corrective and preventive actions arising from Audits
•  Assists in the planning, implementation, monitoring and close out of field corrective actions (FCAs) in the affected countries within the designated territory
• Assist the Regulatory and Quality Manager in product modification reporting and adverse event reporting to regulatory Authorities within the defined territory, as required
• Assists the Regulatory team in supporting business operations for product registrations within the defined territory,
• Assists with the facilitation of product registrations of Alere products in Affiliate and Distributor countries in the defined territory.
• Provides inputsof product registrations status to the Regulatory Specialist and other stakeholders and inputs information to registration trackers where required
• Assisting with inputs and updates into GRID for Africa (Alere Regulatory Database ) through regulatory intelligence gathered via Commercial team, Distributors and authorities in the designated territory.
• Promotes awareness of Quality and Regulatory compliance throughout the organisation /and with distributors through organised training programmes as and when required.

Skills and Attributes

• Strong effective communicator both oral and written and have a command of English
• Good interpersonal skills
• Demonstrated ability to increase productivity and continuously improve methods, approaches, and departmental contribution while remaining cost-sensitive.
• Attention to detail
• Demonstrates reliability to get the assigned work done in accordance within prescribed deadlines
• Communicates constructively to express thoughts and ideas clearly in a positive, confident, and respectful manner.
• Shares openly and willingly information, knowledge, and experience and takes the initiative to keep other team members informed.
• Co-operates and work with others to accomplish tasks in achievement of organizational goals.
• Deals with problems in a solutions-oriented manner and collaborate with others to find solutions and form action plans
• Exhibits flexibility and adaptability in dealing with changing situations, with consideration and compromise to different points of views on order to move forward to making of decisions.
• Shows commitment to the own responsibilities and as well as the overall teams goals and successes.
• Treats others in a respectful and supportive manner consistently.
• Able to assess Quality related issues thoroughly and solves complex problems; and able to removes roadblocks that hinder business growth.
• Able to refine and aligns tools, systems and processes to drive distributor / partners engagement for compliance.

Education and Experience

• Medical Technology Diploma / Bachelors Degree in Science or equivalent
• 3-5 Years experience within the medical industry in Quality / Regulatory/ Product management functions
• Familiar with ISO Quality System standard concepts and procedures will be advantageous
• Certifications an advantage including Quality Auditor,
• Must be willing to travel
• Competent in Word and Excel.