IQ OQ PQ Jobs in Bengaluru

Key Responsibilities: QMS Documentation & Activities: Expertise in preparing and managing QMS (Quality Management System) documentation related to facility and engineering activities, including writing SOPs for lab instruments, equipment, and utilities, as well as preparing qualification documents (DQ, IQ, OQ, PQ), deviation handling, change control, risk assessment, CAPA, and commissioning documents. Cross-functional Collaboration: Work closely with both internal teams and external stakeholders to ensure the smooth implementation and execution of engineering maintenance activities. This includes document preparation, process review, implementation, and follow-ups with various functional teams and vendors. Facility Modification & Commissioning: Manage facility modification projects, including overseeing commissioning and qualifications documentation to ensure that changes are aligned with regulatory and operational standards. Lab Equipment Operations & Maintenance: Oversee the operation and maintenance of lab equipment, including CO2 incubators, deep freezers, autoclaves, biosafety cabinets, LAF, stability chambers, cooling incubators, lab centrifuges, water baths, hot air ovens, incubator shakers, water purification systems, bioreactors, cold rooms, and liquid nitrogen systems. Analytical Instrument Operations & Maintenance: Manage the operation and maintenance of analytical instruments such as flow cytometers, spectrophotometers, multimode microplate readers, chemical image systems, gel image systems, osmometers, pH & conductivity meters, weighing balances, and western blot instruments. Utility Equipment Maintenance: Manage the operation and maintenance of HVAC systems (including air handling units, chillers, cooling towers, and BMS monitoring systems), utility equipment such as transformers, DG sets, air compressors, nitrogen generators, and LT panels. Preventive Maintenance Planning: Prepare and review schedules for periodic maintenance of lab instruments, utility equipment, and facility infrastructure. Ensure that all maintenance activities are conducted timely and in accordance with operational needs. Corrective and Preventive Actions: Coordinate and oversee corrective and preventive actions related to observations during internal and external audits, ensuring continuous compliance with quality standards. Vendor and OEM Coordination: Serve as the primary point of contact for external vendors and OEM service providers for periodic preventive maintenance (PM), calibration activities, and addressing breakdown issues. Project & Facility Modification Support: Coordinate and support the execution, verification, and successful completion of new projects or facility modification activities. Safety and Sustainability: Ensure compliance with safety practices and procedures, sustainability programs, and hygiene maintenance standards across the facility. Key Skills: QMS Documentation: In-depth experience in writing and managing SOPs and qualification documents (DQ, IQ, OQ, PQ) for lab instruments and utility systems. Proficient in handling deviations, change controls, risk assessments, CAPA, and commissioning documentation. Lab Equipment Expertise: Strong knowledge in the operation and maintenance of various lab equipment, including incubators, freezers, autoclaves, biosafety cabinets, stability chambers, centrifuges, and water purification systems. Analytical Instruments Management: Expertise in handling and maintaining analytical instruments like flow cytometers, spectrophotometers, microplate readers, and various other lab-based instruments used for experiments and analysis. Utility Systems & HVAC Management: Strong knowledge of utility equipment management, including HVAC systems, transformers, DG sets, air compressors, and nitrogen generators. Preventive & Corrective Maintenance: Ability to plan, schedule, and execute preventive and corrective maintenance tasks for lab instruments and utility systems, ensuring minimal downtime. Vendor Management: Expertise in coordinating with external vendors and OEMs for service contracts, maintenance, calibration, and addressing equipment failures or breakdowns. Project Coordination: Ability to manage and execute facility modification projects, ensuring timely delivery and alignment with operational needs. Safety & Compliance: Sound knowledge of safety practices, hygiene, sustainability programs, and regulatory compliance within facility and equipment operations. Competencies: Attention to Detail: High level of attention to detail in handling documentation, operational processes, and safety practices. Problem Solving: Strong analytical skills to troubleshoot and resolve issues in equipment, systems, and processes. Interpersonal & Communication Skills: Excellent communication and interpersonal skills to effectively collaborate with internal teams, external vendors, and service providers. Project Management: Ability to manage projects efficiently, ensuring all modifications, installations, and maintenance activities are completed on time and within scope. Team Collaboration: Team-oriented mindset with a collaborative approach to work alongside internal departments and external contractors/service providers. Adaptability: Ability to adapt to changing priorities, work in dynamic environments, and manage multiple tasks simultaneously. Qualification : Diploma/BE in electrical and electronics, with QMS related certifications with 10+Years of experience.