
Senior Production Operations Manager
7 days ago
Job Title: Senior Production Operations Manager
About This RoleThis is a key leadership position within our production team, responsible for overseeing daily operations and ensuring alignment with organizational objectives. As Senior Production Operations Manager, you will manage staff, optimize processes, and quality management systems to maintain high standards.
The ideal candidate will have experience in sterile/aseptic or injectable manufacturing, QMS practices, and compliance-driven production environments. They will possess strong knowledge of cGMP, regulatory audits, and process validations.
We are seeking an experienced professional with hands-on experience in managing production-related QMS elements, reviewing and drafting GMP documentation, equipment troubleshooting, and maintenance coordination. The successful candidate will also be able to manage and optimize manpower deployment, generate performance and compliance reports, and demonstrate strong leadership and team management skills.
Responsibilities- Plan and execute 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.
- 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.
- 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 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.
- 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.
This is an equal opportunity organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.
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