Job Description
Key Responsibilities:
• Ensure compliance of products supplied to the markets with the registered details:
• Liaise with the Regulatory Team/Affiliates to confirm the registered details of the products in the market (e.g. shelf-life, storage conditions, specifications, etc.) and prepare product compliance documents with this information.
• Monitor regulatory approvals and communicate with manufacturing sites for timely implementation.
• Monitor the required qualification status of the suppliers (manufacturers of active pharmaceutical ingredients and finished products):
• Maintain up-to-date relevant documentation, including technical agreements, product quality reviews, stability reports, quality statements, and Excel trackers.
• Review documentation received from manufacturing sites and maintain the relevant trackers (e.g. product quality reviews, stability data).
• Liaise with manufacturing sites for all quality-related items/issues and monitor CAPA completion related to audits.
• Act as the interface between manufacturing sites and distributors, affiliates, and other streams for quality-related items:
• Coordinate investigation of customer complaints with suppliers, logging them in the system and providing responses to the complainant/contact person.
• Handle change controls/requests from manufacturing sites, logging them in the system and monitoring task completion.
• Manage deviations raised by manufacturing sites, logging them in the system and evaluating the impact on the product, supply continuity, and registered details.
• Assist during internal/external audits and inspections.
• Enhance the Quality Management System by identifying and implementing process improvements.
Job Requirements
Requirements (Essential Criteria needed for this role):
• Bachelor's or Postgraduate degree in Chemistry, Pharmacy, or an equivalent degree (Science degree).
• Experience in a Quality Control and Quality Assurance environment is an advantage but not essential.
• Exposure within a pharmaceutical manufacturing site would be advantageous.
• Intermediate to advanced proficiency in Microsoft Office (Excel, Word, and PowerPoint).