Quality Assurance Manager
Current• Establishing and maintaining the documentation system to ensure compliance with regulatory and corporate requirements in the pharmaceutical industry.• Overseeing the implementation and progress of validation and qualification projects, ensuring that they are executed according to established guidelines.• Reviewing and approving process validation for different pharmaceutical products and dosage forms, ensuring their effectiveness and compliance with regulatory standards.•… Show more • Establishing and maintaining the documentation system to ensure compliance with regulatory and corporate requirements in the pharmaceutical industry.• Overseeing the implementation and progress of validation and qualification projects, ensuring that they are executed according to established guidelines.• Reviewing and approving process validation for different pharmaceutical products and dosage forms, ensuring their effectiveness and compliance with regulatory standards.• Participating in the equipment qualification committee, ensuring proper qualification of equipment used in manufacturing processes.• Reviewing and approving cleaning validation procedures, verifying that effective cleaning practices are in place to maintain product quality and safety.• Reviewing and approving major system qualification, specifically HVAC and Water systems, to ensure their proper functioning and compliance with industry regulations.• Conducting thorough investigations into deviations, identifying root causes, and determining appropriate corrective and preventive actions.• Evaluating and reporting on quality complaints, conducting root cause analysis, and preparing comprehensive action plans for resolution.• Monitoring the implementation of action plans to address identified issues, ensuring timely and effective resolution.• Reviewing and approving Standard Operating Procedures (SOPs), verifying their compliance with regulatory requirements and company standards.• Participating in recall initiation, evaluation, and conducting activities, ensuring swift and appropriate actions are taken to address product-related issues.• Conducting MOCK recall testing to evaluate the effectiveness of recall procedures and identify areas for improvement.• Reviewing and approving master batch records, ensuring proper testing protocols and confirming the suitability of finished products before their release to the market.• Managing the change control process, risk assessments, APQR Show less