The role of Quality Assurance Specialist is critical in ensuring compliance with regulatory requirements across all distribution activities.
Job Responsibilities:
* Support the development, implementation, and ongoing maintenance of the Quality Management System (QMS).
* Ensure adherence to regulatory guidelines and standards across all distribution activities.
* Promote a strong quality culture through continuous training, retraining, and effective communication of quality processes.
* Oversee training requirements: ensuring new hires receive initial regulatory training and that a structured ongoing training programme is in place for all employees.
* Verify that only authorized products are sourced from approved suppliers and supplied to approved customers in line with established protocols.
* Assist with the qualification and approval of outsourced service providers and transport routes as required.
* Review, draft, and implement controlled documentation including SOPs, deviations, change controls, validations, and related records.
* Perform initial and ongoing verification checks on suppliers and customers as assigned.
* Contribute to the maintenance of a company-wide risk management culture.
* Review and update Quality Technical Agreements, ensuring agreements are in place with all relevant suppliers, customers, and service providers.
* Manage product returns within the supply chain: secure handling, appropriate reporting to the Responsible Person (RP), and ensuring non-compliant products are not released for sale.
* Assess temperature-controlled shipments and provide quality decisions regarding product impact.
* Monitor all temperature-controlled activities within the supply chain, including warehouse conditions.
* Escalate suspected adverse drug reactions (ADRs) or product quality defects to the RP for reporting to Regulatory Authorities and Product Authorisation holders.
* Coordinate and execute product recalls in a compliant and timely manner.
* Act as Deputy Responsible Person (d RP) on the company's Wholesale Authorization, assuming RP duties during their absence with appropriate handover.
* Execute delegated RP responsibilities and ensure accurate record keeping of these activities.
* Safeguard continuity of supply while ensuring that commercial decisions never compromise product quality, patient safety, or compliance.
* Escalate any suspected falsified medicines to Regulatory Authorities and Product Authorisation holders without delay.
* Maintain accuracy and integrity of quality records and all regulatory-related documentation.
Benefits
* A chance to work in a dynamic environment and contribute to the success of our organization.
* Opportunities for professional growth and development.
* A competitive salary and benefits package.
Required Skills and Qualifications
* Degree in a life science or a related field.
* Experience in a similar role or in a related industry.
* Knowledge of regulatory requirements and standards.
* Strong analytical and problem-solving skills.
* Excellent communication and interpersonal skills.
Others
* A thorough understanding of quality management principles and practices.
* Able to work independently and as part of a team.
* Familiarity with quality management software and systems.
* Ability to travel as required.