Omer Alyas Email and Phone Number

. Daily Operations Oversight Oversee day-to-day plant activities to ensure compliance with quality standards.Review and assess daily quality reports to identify and address any issues promptly.Documentation and Procedure Management Develop, review, and approve work instructions, protocols, and procedures to ensure they meet regulatory and industry standards.Inspections and Audit Prepare for and conduct self-inspections and internal audits to ensure compliance with company policies and regulatory requirements. Participate in the development and execution of internal audit plans to identify areas for improvement.Validation and QQualification Conduct process validation to ensure that production processes consistently produce products that meet quality standards. Perform vendor qualification to ensure suppliers meet the company's quality requirements. Conduct GMP rounds to verify compliance with industry regulations.Quality Management and Issue RResolution Supervise and manage quality elements such as Non-Conformance (NC), market complaints, and management of change (MoC). Implement corrective and preventive actions to address quality issues and prevent recurrence.HACCP Planning Prepare, review, and execute Hazard Analysis Critical Control Point (HACCP) plans to ensure product safety and compliance with food safety regulations.

Ensured Regulatory Compliances Led efforts to ensure all materials, procedures, production areas, and equipment comply with the quality system, guidelines, and NMPB (National Medicines and Poisoning Board) standards, enhancing overall regulatory adherence.Document Management Reviewed and authorized Validation Master Plans (VMPs) and related documentation including process validation, holding time studies, equipment qualification, and temperature mapping analysis, ensuring accuracy and regulatory compliance.Developed Cleaning Validation Protocols Created comprehensive cleaning validation protocols, developed cleaning procedures, calculated Maximum Allowable Carryover (MACO), and determined appropriate cleaning agents, improving the efficacy of cleaning processes.Instrument and Equipment Oversight ensures operational readiness and calibration status of all instruments, devices, and balances, establishing a preventive maintenance schedule to ensure optimal performance and compliance.Quality Control Coordination Collaborated with the Quality Control department to align activities and ensure integration of validation and quality control processes, resulting in improved operational efficiency.Facility Inspections and Audits Conducted thorough inspections and audits of various departments and facilities, identifying gaps in compliance and leading efforts to develop actionable plans to address deficiencies.Action Plan Development Led the creation of comprehensive action plans post-audit to rectify compliance gaps, utilizing root cause analysis and continuous improvement methodologies.Leadership and Team Development: Invested in leadership and professional development, empowering team members through delegation and opportunities for growth, fostering a culture of continuous improvement.Digital Tools and Data Analytics Implementation Introduced digital validation management tools and leveraged data analytics to monitor and improve validation processes.

Daily Activity Monitoring Monitor daily mining operations to ensure adherence to company policies and Health, Safety, and Environment (HSE) regulations.Facility Inspections Perform regular inspections of various DAL mining facilities to ensure compliance with safety and operational standards.Risk Assessment and Control Measures Assess risks, conduct Job Hazard Analysis (JHA) and Job Safety Analysis (JSA) for different tasks and processes, and implement appropriate control measures (ARAP).Documentation and Reporting Prepare and review company procedure documents, including safety instructions, Standard Operating Procedures (SOPs), daily/weekly/monthly/annual reports, incident investigations, and lessons learned.Training and Safety Drills Conduct training sessions, including drills and Tool Box Talk (TBT) sessions, for employees, contractors, and visitors to enhance safety awareness and preparedness.

Quality Management Systems Implement, maintain, and continuously improve various components of the Quality Management Systems, including change control, deviations management system, market complaints, and product recalls.Qualification and Validation Programs Prepare, review, and execute qualification and validation programs such as holding time studies, process validation, equipment qualification, and commissioning and vendor qualification.GMP Compliance Ensure compliance with Good Manufacturing Practices (GMP) by conducting GMP rounds, reviewing documentation, performing self-inspections, and conducting internal audits.GMP Documentation Facilitate the coordination of revising, reviewing, and updating GMP documents to ensure they meet current standards and regulations.Non-Conformance Management Manage non-conformances by conducting root cause analysis and implementing appropriate action plans to address and bridge any gaps.Training Programs Supervise Amipharma Training Programs for new hires, interns, and visitors, ensuring the efficiency and effectiveness of the training provided.

Lab Oversight Supervise practical laboratory activities for undergraduate students in chemical engineering, ensuring adherence to safety protocols and experimental procedures.Conducting Lab Lectures Deliver engaging and informative lab lectures covering topics such as mass and heat transfer, control, and fluid dynamics to undergraduate students.Guidance on Graduation Projects Provide guidance and support to students throughout their practical graduation projects, offering assistance with experimental design, data analysis, and project presentation.Tutorials and Additional Lectures Deliver tutorials and additional lectures to students to supplement their understanding of course material and enhance their learning experience.