Job Summary
We are seeking a detail-oriented and proactive professional to join our manufacturing team in the Ampoules and Eye Drops department. The successful candidate will be responsible for overseeing manufacturing and filling operations, ensuring compliance with GMP, EHS, and regulatory standards, and driving operational excellence. This role demands a strong focus on safety, quality, efficiency, and data integrity while maintaining production targets and promoting continuous improvement.
Key Responsibilities
- Manage manufacturing and filling operations within the Ampoules and Eye Drops department to meet required output targets.
- Strictly adhere to Good Manufacturing Practices (GMP), Environment, Health, and Safety (EHS) protocols, and all relevant regulatory standards.
- Promote a safe working environment by ensuring area safety, advocating for Zero Waste initiatives, and reporting Zero Accident Potential (ZAP) and Zero Injury Potential (ZIP) incidents.
- Maintain accurate and up-to-date records daily, including production data, downtime logs, changeover details, preventive maintenance, and other operational documentation.
- Proactively suggest and implement improvements to enhance Overall Equipment Effectiveness (OEE) and maintain toolkit data for continuous machine efficiency.
- Monitor and ensure production floor Key Performance Indicators (KPIs) are consistently met, focusing on daily OEE targets and adherence to the daily production plan.
- Ensure full GMP compliance, including proper labeling, in-process controls (IPC), and thorough line clearance procedures.
- Uphold EHS compliance by enforcing zero access zones and implementing lockout-tagout (LOTO) procedures rigorously.
- Operate cost-effectively by emphasizing right-first-time production, minimizing changeovers, and reducing waste.
- Identify potential Operational Excellence (OE) projects, propose them for management approval, and lead their implementation to improve processes.
- Maintain comprehensive machine records such as daily logbooks, maintenance reports, cleaning schedules, and changeover documentation.
- Ensure data integrity by adhering to ALCOA+ principles, continuously improving controls to maintain accurate and reliable data.
- Complete all SAP production transactions related to Ampoules and Eye Drops packaging operations promptly and accurately.
- Demonstrate meticulous attention to detail to ensure compliance, accurate record-keeping, and data integrity.
- Apply strong problem-solving skills to identify operational challenges and implement effective solutions.
- Communicate clearly and effectively with team members and management to facilitate collaboration and information sharing.
Required Qualifications
- Proven experience in pharmaceutical manufacturing, specifically in ampoules and eye drops production or similar sterile operations.
- Solid understanding of GMP, EHS, and regulatory compliance requirements in a manufacturing environment.
- Strong knowledge of operational metrics such as OEE and experience in maintaining production KPIs.
- Proficiency in maintaining detailed production and maintenance records.
- Familiarity with SAP or similar ERP systems for production transaction management.
- Excellent problem-solving abilities and a continuous improvement mindset.
- Effective communication skills to collaborate with cross-functional teams and management.
- Commitment to safety, quality, and data integrity standards including ALCOA+ principles.
Preferred Qualifications and Benefits
While not explicitly mentioned, candidates with experience in Operational Excellence projects and a background in implementing lean manufacturing or Six Sigma methodologies will be highly valued. The role offers an opportunity to contribute to a high-standard manufacturing environment focused on safety, quality, and efficiency.
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This position is ideal for professionals dedicated to maintaining high standards in pharmaceutical manufacturing while driving continuous improvement and operational excellence. If you are detail-driven, safety-conscious, and eager to contribute to a dynamic team, we encourage you to apply.