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Production Operations Manager
2 weeks ago
This role involves overseeing daily production operations, ensuring alignment with company objectives and strategic plans.
Main 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 (QMS) elements such as Change Control, Deviations, Corrective Action and Preventive Action (CAPA), and Event Investigations.
- Review and prepare production-related documents, including standard operating procedures (SOPs), batch manufacturing records (BMRs), and batch production records (BPRs).
- Conduct training programs and evaluations on current Good Manufacturing Practices (cGMP) and SOPs as per schedule or training need identification.
- Troubleshoot production issues and ensure timely resolution to avoid operational delays.
- Ensure 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.
Necessary Skills and Qualifications:
- Bachelor's or master's degree in a relevant field, such as pharmacy, life sciences, biotechnology, or a related discipline.
- 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, Delta series harvestorsystems, PFS filling machines, mixing vessels, and packing lines.
- Understanding of utilities such as diesel generators, high tension panels, power transformers, etc.
Required Functional Skills:
- 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.
Desired 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.
Authorized Responsibilities:
- 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.
