Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value-added sterile injectables that address critical gaps in healthcare delivery.
By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide.
Responsibilities:
- Supervise daily manufacturing operations including formulation, filling, and packaging of sterile injectable IV bag products within cleanroom environments utilizing isolator technology.
- Manage and develop production team members, providing coaching, training, and performance feedback to ensure adherence to standard operating procedures (SOPs) and quality expectations.
- Author, review, and approve SOPs, batch records, and other production documentation to ensure compliance with cGMP and regulatory requirements.
- Ensure compliance with cGMP, FDA, DEA, OSHA, and other regulatory requirements, particularly in handling high potent APIs and controlled substances.
- Coordinate production schedules to meet demand and support planning, warehouse, and materials management functions.
- Monitor key performance indicators (KPIs) for productivity, quality, and safety; implement corrective and preventive actions as needed.
- Oversee line clearance, equipment setup, and cleaning activities, ensuring readiness for manufacturing operations and minimizing downtime.
- Support deviations, investigations, and CAPA implementation in partnership with Quality Assurance and other support functions.
- Drive continuous improvement initiatives to enhance operational efficiency, product quality, and operator engagement.
- Ensure effective communication between production shifts and other departments to maintain smooth and efficient operations.
- Maintain a strong safety culture, ensuring compliance with Environmental Health & Safety (EHS) programs and best practices.
Requirements:
Qualifications/Experience:
- Bachelor’s degree in engineering, Life Sciences, or a related technical field preferred; equivalent experience considered.
- Minimum of 3–5 years’ experience in pharmaceutical or biotechnology manufacturing, preferably in sterile or aseptic operations.
- Supervisory experience leading production teams in a regulated environment.
- Knowledge of cGMP, aseptic processing, and isolator-based manufacturing.
- Experience with high potent APIs and/or controlled substances preferred.
- Proficiency with production documentation, batch records, SOP authoring, and deviation processes.
Requirements:
Skills / Competencies:
- Strong leadership and team management skills with a focus on employee development.
- Excellent organizational and problem-solving abilities.
- Ability to manage multiple priorities in a fast-paced, dynamic environment.
- Clear, concise communication skills (written and verbal).
- Proficiency in Microsoft Office and familiarity with manufacturing execution systems (MES) or ERP platforms.
- Commitment to data integrity, safety, and continuous improvement.