
Operations Director for Pharmaceutical Manufacturing
2 days ago
**Key Role: Production Operations Manager**
This role is critical to ensuring the smooth operation of daily activities in alignment with company objectives. The successful candidate will oversee production staff, optimize processes, and maintain high standards of quality management systems.
Responsibilities:
- Plan and execute daily production schedules to meet operational goals.
- Supervise production staff, resolving conflicts and supporting professional development.
- Monitor and maintain production-related QMS elements, including Change Control, Deviations, CAPA, and Event Investigations.
- Review and prepare production-related documents, such as SOPs, BMRs, and BPRs.
- Conduct training programs and evaluations on cGMP and SOPs as per schedule or Training Need Identification.
- Troubleshoot production issues and ensure timely resolution to avoid operational delays.
- 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.
- C coordinate with the maintenance team to resolve equipment breakdowns.
- Oversee document control to ensure integrity and accessibility of quality records.
- Liaise with cross-functional departments for 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 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, including Diesel Generators, HT Panels, Power Transformers, etc.
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.
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.
We are an equal opportunity organization promoting diversity and inclusion.
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