Operational Lead

24 hours ago

Udaipur, Rajasthan, India beBeeProductionManager Full time ₹ 16,62,500 - ₹ 24,17,500
Job Description

Key Responsibilities:

  • Develop and implement daily production schedules to meet operational objectives.
  • Lead and motivate production staff; resolve conflicts and foster professional growth.
  • Monitor and maintain production-related quality management systems, including Change Control, Deviations, CAPA, and Event Investigations.
  • Review and prepare production-related documents, such as Standard Operating Procedures (SOPs), Business Process Reviews (BPRs), and Batch Manufacturing Records (BMRs).
  • Conduct training programs and evaluations on Current Good Manufacturing Practices (cGMP) and SOPs as per schedule or Training Need Identification (TNI).
  • Troubleshoot production issues and ensure timely resolution to avoid operational delays.
  • Ensure adherence to SOPs, protocols, and regulatory standards in all processes and documentation.
  • Maintain accurate and up-to-date records, including batch records, equipment logs, and quality reports.
  • Generate and submit reports on production performance, efficiency, and quality metrics.
  • Coordinate with the maintenance team to ensure timely resolution of equipment breakdowns.
  • Oversee document control to ensure integrity and accessibility of quality records.

Required Skills and Qualifications:

  • Bachelor's or master's degree in pharmacy, life sciences, biotechnology, or a related field.
  • Minimum 6–10 years of relevant experience in sterile/aseptic or injectable manufacturing.
  • Hands-on experience in Quality Management Systems (QMS) practices and compliance-driven production environments.
  • Knowledge of cGMP, regulatory audits, and process validations.
  • Proficiency in handling process equipment, such as autoclaves, DHS systems, PFS filling machines, mixing vessels, and packing lines.
  • Understanding of utilities, including Diesel Generators, HT Panels, Power Transformers, etc.

Benefits:

  • Leadership and team management opportunities.
  • Decision-making and problem-solving challenges.
  • Strong communication and interpersonal skills development.
  • Time management and ability to handle pressure.
  • Continuous improvement mindset.
  • Proactiveness and accountability.

Authority:

  • Authorized to review, approve, and manage GMP documents within the Production department.
  • Authorized to plan and allocate production resources, including manpower distribution.
  • Authorized to execute and monitor training programs for production and engineering teams.
  • Authorized to coordinate with Engineering for maintenance and utility management.

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