
Production Management Specialist
24 hours ago
We are seeking a highly skilled and experienced Senior Operations Manager to join our team. The successful candidate will be responsible for overseeing the daily operations, ensuring that all activities are conducted in alignment with company objectives.
This is a key role within the organization, requiring strong leadership skills, strategic thinking, and the ability to motivate and develop a team of production staff.
- Key Responsibilities:
- Plan and execute daily production schedules to meet operational goals.
- Supervise and motivate production staff, resolving conflicts and supporting professional development.
- Monitor and maintain production-related quality management systems (QMS) elements.
- 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 practices (cGMP) and SOPs.
- 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, 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 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 a relevant field, such as 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, including autoclaves, diesel generators, high-tension panels, power transformers, etc.
- Strong knowledge of QMS tools, including 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.
- 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.
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