Sterile Manufacturing Operations Leader

20 hours ago

Thiruvananthapuram, Kerala, India beBeeProductionManager Full time ₹ 15,00,000 - ₹ 25,00,000

ROLE OBJECTIVE

This role involves overseeing daily operations and ensuring activities are conducted in line with company objectives. The Assistant Manager Production is responsible for managing staff, optimizing processes, and maintaining quality management systems.

Key Responsibilities:

  • Assist in planning and executing daily production schedules to meet operational goals.
  • Supervise and motivate production staff; resolve conflicts and support professional development.
  • Monitor and maintain production-related QMS elements such as Change Control, Deviations, CAPA, and Event Investigations in track-wise systems.
  • Review and prepare production-related documents, including SOPs, BMRs, and BPRs.
  • Conduct training programs and evaluations on cGMP and SOPs as per schedule or Training Need Identification (TNI).
  • Troubleshoot production issues and ensure timely resolution to avoid operational delays.
  • Ensure all processes and documentation are carried out in accordance with SOPs, protocols, and regulatory standards.
  • Maintain accurate and up-to-date records such as 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 the document control process to ensure integrity and accessibility of quality records.
  • Liaise with cross-functional departments to facilitate seamless production activities.

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 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 such as Diesel Generators, HT Panels, Power Transformers, etc.

Benefits:

  • Leadership opportunities.
  • Professional growth and development.
  • Competitive compensation package.
  • Equal opportunity organization promoting diversity.

Others:

  • 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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