
Senior Production Operations Specialist
12 hours ago
**Job Overview**
Assistant Manager Production Role
This is a key leadership position responsible for overseeing daily operations and ensuring that all activities are conducted in alignment with company objectives. The Assistant Manager Production will be expected to step in and take charge in the absence of the manager, ensuring the seamless continuation of operations.
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 quality management systems 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 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.
Requirements:
- 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 quality management system practices and compliance-driven production environments.
- Knowledge of cGMP, regulatory audits, and process validations.
- Proficiency in handling process equipment such as autoclaves, diesel generator sets, power transformer panels, and filling machines.
- Understanding of utilities such as diesel generators, high tension panels, and power transformers.
Functional Skills:
- Strong knowledge of quality management 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:
- 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.
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