
Senior Operations Manager
1 day ago
- Job Description:
- As a Senior Operations Manager, you will play a crucial role in planning and executing daily production schedules to meet operational goals.
- You will oversee and motivate production staff; resolve conflicts and support professional development.
- Key Responsibilities include monitoring and maintaining production-related QMS elements such as Change Control, Deviations, CAPA, and Event Investigations in track-wise systems.
- Additionally, you will 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.
- 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.
- Required Skills and Qualifications:
- 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.
- Functional Skills Required:
- 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.
- Behavioral Skills Required:
- 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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