Quality Assurance and Regulatory Compliance R& D Director

Summary about this job

Detail information about job Quality Assurance and Regulatory Compliance R& D Director. Terms and conditions vacancy

The Quality Assurance and Regulatory Compliance R& D Director will report to the Partner & EVP or other Senior Level Management as required. You will be responsible for the global oversight of Quality Assurance, Good Production Practices, quality control systems and regulatory audit environments as required.

Your daily responsibilities will include:

Administration & Management

• Implement protocols to ensure the cleanliness of the premises and equipment;
• Develop documents used in Good Manufacturing Practices, Good Production Practices, and Good Agricultural Practices following EU GMP Annex 7: Manufacture of Herbal Medicinal Products
• Provide technical guidance and training/mentoring to other QA employees and cross-functional teams;
• Develop training programs and supervise implementation of QA Procedures;
• Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness;
• Implement and enforce regulatory compliance programs;
• Produce, approve, and update Standard Operating Procedures as required;
• Manage document control and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness;
• Manage non-conformance, corrective action preventive actions and deviation;
• Develop and implement departmental and divisional policies and procedures;
• Review completion of inventory tracking logs for accuracy and completeness;
• Ensure that all jurisdiction of the company is compliant with federal and local requirements;
• Train and manage QA team members’ performance;

Quality Assurance & Regulatory Compliance

• Arrange testing of dried cannabis and cannabis oil for microbial and chemical contaminants;
• Validate analytical testing;
• Manage and approve the quality of processed goods prior to making it available for sale;
• Prepare and monitor product conformity and stability program;
• Enforce environmental surveillance and hygiene control;
• Inspect production resources, packaging and medicinal material, and issue inspection reports;
• Prepare test protocols to support regulatory submissions;
• Prepare submissions including design and manufacturing changes and labelling;
• Review and sign off on product and manufacturing changes for compliance with applicable regulations;
• Establish & conduct product recalls as necessary, including informing the regulator of a recall and the reason(s) for it;
• Monitor audits of quality control areas;
• Review device labelling and advertising materials for compliance with global regulations; analyse and recommend appropriate changes;
• Prepare and manage quality control documentation and manage all forms of original records concerning production, packaging, sanitation, and inspection;
• Prepare test protocols to support regulatory submissions;
• Update Risk Management files and provide input in design verification, design validation, shelf life studies; and
• Support Regulatory submissions/renewal and on-going regulatory compliance for product development process.

Please email all CV's to [email protected]