Администратор ОТиТБ

Regulatory & GMP Compliance

• Ensure compliance with Uzbek EHS legislation, Sanepid, Ecology, and Labor authorities, as well as international GMP/EHS standards.
• Develop, implement, and continuously update EHS management systems (ISO 14001, ISO 45001) in alignment with GMP.
• Prepare and maintain all EHS documentation, including SOPs, risk assessments, and validation-related EHS requirements.
• Support internal and external audits (EU GMP, WHO, MOH Uzbekistan) related to EHS compliance.

Plant Safety & Risk Management

• Conduct GMP-oriented risk assessments for all process and utility areas — including granulation, coating, compression, filling, lyophilization, and sterilization.
• Ensure safe operations in HVAC areas, sterile zones, cleanrooms (Grade A/B/C/D), and utility systems (WFI, Clean Steam, Compressed Air, etc.).
• Implement Lockout/Tagout (LOTO), Permit to Work, Confined Space Entry, and Machine Guarding programs.
• Establish Emergency Response Plans (fire, chemical spills, utility failure, contamination risk, etc.) with regular drills and training.

Environmental Management

• Oversee the operation of ETP/STP, air emission control systems, and hazardous/non-hazardous waste segregation.
• Ensure proper disposal of solvents, reagents, and bio-waste in line with Uzbek environmental norms.
• Monitor and report environmental KPIs — water, energy, waste, and emission reduction initiatives.
• Coordinate with local authorities for environmental permits, audits, and sustainability programs.

Health & Occupational Hygiene

• Conduct occupational health risk assessments for exposure to APIs, solvents, dust, and sterilants.
• Implement occupational monitoring (noise, air quality, particulate matter) in compliance with GMP and local laws.
• Coordinate with medical and HR teams for periodic health surveillance of employees.

Construction & Project Phase

• Ensure all contractors comply with EHS norms during construction, installation, commissioning, and qualification phases.
• Review layout drawings, HAZOPs, and project plans to identify EHS risks early in design.
• Approve contractor safety plans and monitor daily EHS performance on site.

Training & Culture Building

• Design and conduct EHS & GMP safety training for all levels — management, operators, engineering, and contractors.
• Build a Zero Incident Culture through awareness drives, campaigns, and behavior-based safety initiatives.
• Conduct induction programs for new employees and vendors on GMP safety requirements.

Qualifications & Experience:

• Bachelor’s or master’s degree in environmental science, Industrial Safety, Chemical Engineering, or Pharmacy.
• 8–10 years of experience in Pharmaceutical Manufacturing (OSD + Sterile) with strong knowledge of GMP-based EHS systems.
• Certified in NEBOSH / IOSH / ISO 45001 / ISO 14001 preferred.
• Working knowledge of Uzbek EHS regulations, and international standards (OSHA, EU-GMP, WHO, ICH).
• Strong command of knowledge of Russian or Uzbek and English will be an added advantage.

Key Competencies:

• Deep understanding of pharma GMP processes and cleanroom safety.
• Strong analytical, risk assessment, and root cause analysis skills.
• Effective leadership and training capabilities.