Assistant Manager / Deputy Manager / Manager - Manufacturing the Role
We are seeking a seasoned professional to lead and manage sterile manufacturing operations, ensuring adherence to regulatory standards, Good Manufacturing Practices (cGMP), and organizational quality goals.
The ideal candidate will possess extensive experience in sterile production, process validation, and documentation management within a pharmaceutical environment, complemented by strong managerial and business acumen.
Key Excellence :
- Oversee sterile manufacturing operations including dispensing, compounding, filtration, filling, sealing, labeling, and packing activities.
- Ensure smooth execution of daily and monthly production planning, aligned with material availability and production targets.
- Maintain validated and calibrated status of all manufacturing equipment and lines.
- Supervise and monitor adherence to cGMP, GDP, and safety protocols within the department.
Documentation & Compliance :
Prepare, review, revise, and implement Standard Operating Procedures (SOPs) for sterile manufacturing.Manage and control master documents such as Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and master SOPs.Prepare and review protocols, reports, and production documentation as per regulatory and organizational requirements.Handle Change Controls, Deviations, CAPA, and Investigations in compliance with quality standards.Maintain manufacturing records, equipment logs, and ensure facility readiness for internal and external audits or inspections.Training & Team Management :
Lead, mentor, and train subordinates, technicians, and operators to enhance technical capability and compliance awareness.Conduct and ensure participation in training programs as per the Training Need Identification (TNI) plan.Promote discipline, teamwork, and continuous improvement within the manufacturing team.Continuous Improvement & Facility Readiness :
Identify and implement process improvements to optimize productivity and reduce deviations.Ensure the manufacturing area and equipment remain in a state of control and inspection readiness at all times.Collaborate cross-functionally with QA, QC, and Engineering teams for smooth plant operations.Key Skills & Competencies :
Sterile Manufacturing Operations : Proficient in filling, sealing, sterilization, and filtration processes.Process Validation & Troubleshooting : Strong knowledge of validation protocols, equipment qualification, and problem-solving.Documentation & Compliance : Excellent understanding of documentation control, GDP, and regulatory guidelines.Technical Expertise : Skilled in CIP / SIP operations, sterilization and depyrogenation, and filtration systems.Leadership : Ability to lead cross-functional teams, manage shop-floor personnel, and ensure performance accountability.Analytical & Business Acumen : Strong planning, decision-making, and resource optimization skills.Qualifications & B.Pharm / M.Pharm; MBA (Operations / Production Management / General Management) preferred.
Experience : 15 to 18 years of experience in sterile manufacturing operations within a reputed pharmaceutical organization.
Preferred Background : Hands-on experience in aseptic processing, process validation, and sterile facility management
(ref : iimjobs.com)