
Operations Coordinator
1 day ago
The key objective of this role is to oversee daily production operations, ensuring alignment with company objectives. This involves effective management of staff, process optimization, and quality management system (QMS) implementation.
Key Responsibilities:- Assist in planning and execution of 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 Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Batch Processing Records (BPRs).
- Conduct training programs and evaluations on Current Good Manufacturing Practice (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.
- 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.
- Strong leadership and team management skills.
- Ability to review and draft GMP documentation.
- Equipment troubleshooting and maintenance coordination expertise.
- Good understanding of production equipment and utility systems.
- Capability to manage and optimize manpower deployment.
- Competence in generating performance and compliance reports.
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