
Senior Operations Manager
17 hours ago
Job Title: Senior Operations Manager
">Role Overview:
">This role involves overseeing the daily operations and ensuring all activities align with business objectives. The successful candidate will manage a team, optimize processes, and implement quality management systems.
">Key Responsibilities:
">- Develop and execute daily production schedules to meet operational goals.">
- Lead 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 in track-wise systems.">
- Review and prepare production-related documents, including SOPs, BMRs, and BPRs.">
- Deliver 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 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.">
Desired Candidate Profile:
">- Strong leadership and team management skills.">
- Excellent decision-making and problem-solving abilities.">
- Effective communication and interpersonal skills.">
- Ability to handle pressure and prioritize tasks effectively.">
- 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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