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Senior Production Operations Specialist
2 weeks ago
The role of the assistant production manager involves overseeing daily operations and ensuring that all activities align with company objectives. This position entails managing staff, optimizing processes, and maintaining quality management systems to high standards.
- 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 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.
Bachelor's or master's degree in pharmacy, life sciences, biotechnology, or a related field is required. A minimum of 6–10 years of relevant experience in sterile/aseptic or injectable manufacturing is necessary. Hands-on experience in QMS practices and compliance-driven production environments is also essential.
- 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.
Biotech is an equal opportunity organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.