Production Oversight Specialist

2 weeks ago

Vizag, Andhra Pradesh, India beBeeOperations Full time ₹ 15,00,000 - ₹ 25,00,000

Job Title: Operations Manager

 

The ideal candidate will oversee daily operations and ensure alignment with company objectives.

 

Key Responsibilities:

  • Plan and execute daily production schedules to meet operational goals.
  • Supervise and motivate production staff; resolve conflicts and support professional development.
  • Monitor and maintain production-related quality management systems (QMS) elements such as Change Control, Deviations, CAPA, and Event Investigations in track-wise systems.
  • Review and prepare production-related documents, including Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Batch Production Records (BPRs).
  • 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 that 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.

 

Desired Candidate Profile:

  • Bachelor's or master's degree in a relevant 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, dynamic holding systems, filling machines, mixing vessels, and packing lines.
  • Understanding of utilities such as diesel generators, high-tension panels, power transformers, etc.

 

Functional Skills Required:

  • Strong knowledge of QMS tools (Deviation, CAPA, Change Control, etc.).
  • Ability to review and draft GMP documentation.
  • Equipment troubleshooting and maintenance coordination.
  • Good understanding of production equipment and utility systems.
  • Capability to manage and optimize manpower deployment.
  • Competence in generating performance and compliance reports.

 

Behavioral Skills Required:

  • Leadership and team management.
  • Decision-making and problem-solving.
  • Strong communication and interpersonal skills.
  • 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.

 

©2024. Biotech is an equal opportunity organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

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