Quality Assurance Manager Job in Dr Darwin Lab

Key Competencies:

• Passion for Excellence
• Leadership & Team Management
• Result Orientation & Multi Tasking
• Good Communication Skills
• Head Quality is accountable for ensuring the all-time readiness of plant for various GMP compliance audits, being the single point contact on all Quality matters.

Quality Assurance:

• Develop, implement, manage, audit and maintain GMP quality systems.
• Coordinate and perform all vendor qualification and compliance audits.
• Develop, manage and maintain a GMP compliant document control system.
• Oversee investigations of all non-conformances (deviations, errors etc.).
• Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company.
• Work across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
• Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change management programs throughout the company.
• Provide quality guidance to product development projects and programs.
• Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.
• Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being - fit for purpose- operationally and commercially.
• Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies.
• Ensuring that there is a self inspection programme in place which is communicated to Operations to meet the requirements of cGMP guidelines.