Biotech Production Operations Specialist

19 hours ago

Ahmedabad, Gujarat, India beBeeProductManager Full time ₹ 18,00,000 - ₹ 25,00,000

About Our Job

The Biotech Assistant Manager Production is a pivotal role that oversees daily operations and ensures alignment with organizational objectives. This entails managing staff, optimizing processes, and maintaining quality management systems at high standards.

Job Responsibilities:

  • Assist in planning and executing daily production schedules to meet operational goals.
  • Supervise and motivate production staff; resolve conflicts and support professional development.
  • Maintain production-related QMS elements, including Change Control, Deviations, CAPA, and Event Investigations.
  • Review and prepare production-related documents, such as 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, 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.
  • 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, including Diesel Generators, HT Panels, Power Transformers, etc.

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