Lead Hazard and Operability (HAZOP) studies for new and existing processes during Management of Change (MoC).
Provide actionable recommendations to ensure process safety.
Risk Assessments :
Overview risk assessments for various activities as needed.
Overview given feasible safety recommendations based on the assessments.
Implement and ensure compliance with the recommended safety measures.
Process ScaleUp :
Analyze and assess risks during process scaleup.
Propose & review solutions for inherently safe designs.
Process Safety Evaluations :
Check the conducted safety assessments for all new and critical processes during design and manufacturing phases.
Check & reviews prepared process safety guidelines before release across all sites.
Technical Guidance :
Review concept notes on Good Engineering Practices (GEP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) to all sites prepared by the corporate process safety team.
Review and approve hazard checklists for new processes prior to scale of commercial manufacturing.
Technology Implementation :
Develop and execute plans for implementing new technologies and practices at various sites.
Evaluate and review Process Flow Diagrams (PFDs) and Piping & Instrumentation Diagrams (P&IDs) for new projects from a safety perspective.
Research and Development Support :
Advise the R&D team on inherently safe design principles.
Customer and Regulatory Interaction :
Respond to customer queries related to process safety.
Centralized Safety Laboratory Management :
Overview of the centralized process safety laboratory at Nerul.
Approve and interpret laboratory reports before release to project owners.
Incident Investigation :
Lead the incident investigations and provide technical inputs to the investigation team.
Organize and monitor monthly "Learning from Incident" sessions.
Corrective and Preventive Actions (CAPA) :
Implement and review global CAPA initiatives based on learnings from incidents.
Eliminate the hurdles at the site for smooth implementation of CAPA.
Management of Change (MoC) :
Lead the meetings of management of change and provide technical inputs to the team.
Regulatory Audit Preparation :
Guide for preparing for regulatory audits, such as those by the Pharmaceutical Supply Chain Initiative (PSCI).
Assess the facilities for readiness to face the audits.
Site Audits and Action Plans :
Audit various sites and develop action plans to address nonconformities observed during visits.
Audit various sites to increase the competency of sites.
Occupational Hazard Solutions :
Offer solutions to site EHS teams to mitigate occupational hazards.
Corporate Support :
Support the corporate environment and safety pillar in implementing guidelines and programs.
Qualification : BE Chemical
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Lead Safety • Republic Of India, IN
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