Manager – Ophthalmic Production | Lupin | Indore

Job Description

Roles and Responsibilities:

• Execution, coordination, review & closure of Batch Document, SIP validation, and Process Simulation Study (Media Fill).
• Optimum utilization of resources like man, material, machine, and energy for quality manufacturing and packing operation.
• Planning, supervision, and execution of sterile complex product manufacturing, Aseptic, and Packing operations
• To maintain a high degree of discipline in the work area & to report any non-conformities, non-adherence, deviation, or procedural gaps to the immediate superior.
• To conduct Risk assessment studies, and plant Audits and ensure compliance of recommendations, active involvement in Event investigations, and compliance of proposed CAPAs and Process safety on the shop floor.
• Regulatory Audit Exposure ( Direct Involvement) FDA, MHRA, TGA
• Expertise in day-to-day troubleshooting on the shop floor with a clear understanding of long-term remediation.
• Identifying & executing continuous improvement actions and projects
• Drive operation excellence projects (OEE improvement, productivity enhancement, change over time reduction).
• Managing the entire extent of Manufacturing Operations including resolving the problems and updating the same periodically with the actions.
• Leading planning and manpower allocation; collaborating with external agencies & customer service department, providing training to Associates/Operators, and identifying the needs for the same.
• Maintaining compliance with standards pertaining to the industry and reporting internal audit information.
• Identifying and roll out of alternate vendor development for supply security and cost improvement.
• Coordination with Q.A., Packing, Quality Control (Micro and Chemical), Engineering and Utilities department for Production activity and its documentation
• Exposure to regulatory audit i.e. USFDA

Key Skill:

• Sterile SME
• Able to handle Investigation and QAMS activity.
• Impart training to Teams for Sterile operations and Behaviors.
• Budgets skill
• Impact evaluation/Risk assessment
• All-time Audit Readiness
• Meet Market requirements (C vs A)
• Adhere to cGMP AND Safety norms.

Must Skill:

• Good Communication & Presentation Skill
• Interpersonal Skill
• Have worked in a USFDA plant.
• Result-oriented mindset.
• Analytical thought process
• Decision-Making Skill

Qualification: B. Pharma, M.Pharma

Experience: 12-16 Years