
Production Operations Director
3 days ago
Job Description:
The Production Operations Director will oversee daily operations, ensuring alignment with company objectives. This role involves 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.
- 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 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.
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:
- A competitive salary and benefits package.
- Ongoing training and professional development opportunities.
- A collaborative and dynamic work environment.
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.
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