Quality Assurance Supervisor at Orange Drugs

Key Responsibilities:

• Provide concise conclusions and summaries of test results for samples, including products, materials, stability testing, temperature mapping, and environmental monitoring.
• Oversee validation and qualification activities.
• Collaborate with Materials department personnel to establish requirements for external suppliers.
• Monitor performance by collecting relevant data and generating statistical reports.
• Identify pertinent quality-related training needs and assist the Quality Assurance Manager in delivering training.
• Establish clear quality practices and standards for all personnel.
• Develop the annual validation master plan and ensure its implementation.
• Ensure that equipment changes undergo necessary risk assessment.
• Conduct required risk assessments and monitor mitigation plans for identified hazards.
• Initiate CAPA forms for deviations as needed.
• Regularly update and monitor the CAPA tracker.
• Keep abreast of updates from WHO/ICH/NAFDAC websites, including WHOPIRs, Regulations, and Pharmacopoeias on a quarterly basis.

Job Factors:

• Supervision of Documentation Officer, Validation Officer, and In-Process Control Officers.
• Internal/External Relationships:
• Engage with Production, Warehouse, Sales and Marketing, Human Resources/Admin, Business Support team, and Engineering personnel on matters concerning factory GMP operations and Regulatory affairs.
• Collaborate with Materials Manager regarding materials management.

Qualifications:

• Bachelor's degree in Industrial Chemistry/Biochemistry/Pharmacy/Pharmaceutical Sciences.
• Minimum of 3 years of experience in Pharmaceutical Manufacturing.
• Demonstrated high level of integrity, expertise in GMP, Chemistry, and Pharmaceutical technology, and the ability to work with minimal supervision.
• Perform duties within agreed specifications and timelines.