Production Coordinator

Production Coordinator

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

The Production Coordinator is an Operator III-level role responsible for independently supporting the manufacture of active pharmaceutical ingredients (APIs), intermediates, and other materials in accordance with cGMP requirements, established procedures, and site safety and quality standards. In addition to performing Operator III responsibilities, the Production Coordinator helps coordinate day-to-day production activities, supports production scheduling and communication, and serves as a key liaison between Production, Quality Control (QC), and Quality Assurance (QA). This role supports effective execution of the production schedule by identifying priorities, facilitating communication across functions, escalating potential constraints, and ensuring timely follow-up on operational activities.

Key duties include:

• Perform all applicable Operator III responsibilities related to the safe and compliant manufacture of APIs, intermediates, and other materials.
• Coordinate and maintain the In-Process Control (IPC) schedule, communicate testing priorities and required timing with Production and QC, and escalate potential delays or conflicts that could impact production execution.
• Coordinate and participate in POD meetings, providing production status updates, identifying constraints or risks, communicating upcoming priorities, and tracking action items through completion.
• Lead and/or facilitate Tier 1 meetings and actively participate in Tier 2 meetings, ensuring key safety, quality, delivery, staffing, and operational issues are communicated, appropriately escalated, and followed through to resolution.
• Serve as a primary liaison between Production, Quality Control (QC), and Quality Assurance (QA) to coordinate priorities and handoffs associated with sampling, testing, documentation review, investigations, batch progression, and other activities necessary to support the manufacturing schedule.
• Monitor day-to-day production activities against the established schedule and proactively communicate changes, delays, resource constraints, or other issues that may affect manufacturing priorities.
• Support production leadership in coordinating daily and near-term manufacturing activities, including equipment availability, material readiness, documentation, testing requirements, and other dependencies necessary for successful execution.
• Facilitate timely communication between production shifts and supporting departments to ensure priorities, outstanding actions, and critical operational information are effectively transferred.
• Review production documentation and work activities for completeness and compliance and promptly identify or escalate documentation, quality, or operational concerns.
• Support the investigation and resolution of production-related issues by gathering information, coordinating with appropriate departments, and assisting with follow-up activities and corrective actions.
• Provide feedback to Production supervision and Technical Operations/Technology Transfer regarding manufacturing processes, equipment performance, procedural improvements, and opportunities to improve safety, quality, efficiency, and schedule adherence.
• Ensure manufacturing activities are performed in accordance with current Good Manufacturing Practices (cGMP), site procedures, safety requirements, and applicable regulatory standards.
• Support equipment preparation, operation, cleaning, setup, and other manufacturing activities as required to maintain production schedules.
• Assist with monitoring raw materials, supplies, equipment, and other production needs and communicate potential shortages or constraints before they affect scheduled manufacturing activities.
• Maintain accurate, complete, and contemporaneous production documentation in accordance with site procedures and data integrity expectations.
• Promptly communicate deviations, atypical events, equipment issues, quality concerns, or other conditions that could impact product quality, employee safety, or production schedules.
• Serve as a resource to Operator I and Operator II employees by providing guidance, answering operational questions, reinforcing procedures and expectations, and supporting on-the-job training as appropriate.
• Promote effective teamwork and communication across shifts and functional groups and model expected standards for safety, quality, compliance, accountability, and professionalism.
• Perform other duties and responsibilities as assigned in support of Production operations.

Education/Experience:

• High school diploma or equivalent.
• Two (2) year diploma from an accredited institution or equivalent experience strongly preferred.
• Two (2) years minimum experience as Chemical Operator II or equivalent experience in a batch chemical manufacturing environment.

Piramal Pharma Limited