Job description
Division Overview:
Eugia’s mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia’s capabilities to include the manufacture of highly complex injectables to answer that need.
Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals. Job Overview:
Eugia is US-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best-in-class, dedicated manufacturing and R&D capabilities to meet customer needs as they emerge. We are committed to consistently providing our customers with high quality specialty medicines.
Eugia’s mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia’s capabilities to include the manufacture of highly complex injectables to answer that need.
Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals.
IPQA Supervisor will support and assist activities related to the production of pharmaceutical products in accordance with current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs) and batch record specification. The IPQA Associate shall assure compliance with all standards and regulatory guidelines.
Responsibilities:
- Supervise IPQA activities at shop floor.
- Preparation and review of Annual Product Review - APR
- Writes Protocols, CAPAS & Deviations as assigned and with guidance
- Participate in the execution of validation and process improvement activities
- Review and approvals of QRM’s and Mitigation action items as part of QRM closure.
- Handling of Out of specification, out of trends, and Environmental excursions.
- Ensuring the implementation of CAPA and performing its effectiveness review.
- Assessing the impact of the changes and ensure the closure of Change Controls as per procedure.
- Responsible for review the master formulae records, manufacturing records and Batch release.
- Providing training to shop floor people.
- Execution of line clearances (Rooms / Equipment) and verification of start-up activities and In-Process checks.
- Monitors compliance in Manufacturing, Packaging, Product Development/Technical Services (PDTS) and Warehouse areas
- Performs AQL Sampling and inspection
- Monitor and maintain cGMP activities at the plant.
- Carrying out of Media fill validation, process validation and cleaning validations.
- Preparation/review of SOP’s and BMRs and BPRs.
- Ensuring online documentation during manufacturing.
- Involve investigations to determine root cause and corrective actions. Review of documents of respective areas and logbooks for adequacy and completeness.
- Good communication skills and capable of communicate with all levels Be able to work long hours to support production requirements Be available for overtime, including weekends, as needed for production support A familiarity with cGMPS, CFRs, OSHA and FDA regulations.
Minimum of 6-8 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.
Physical Requirements: LAB TECHNICIANS -Must be able to bend at the waist and knees as well as twist at the trunk. •Must practice good personal hygiene •Must be able to lift up to 25 lbs. •Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. •Position requires working in the laboratory as well as sitting Additional Physical Requirements: Sitting 1-4 Hours Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
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