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 Associate 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:
- 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.
- Review and Approve Preventive Maintenance or Work Orders (if necessary)
- Verify and confirm issuances and reconciliation of product and components.
- Revise SOP as needed and initiate Change Controls
- Ensuring that all production steps and controls are executed in compliance with GMP and Standard Operating Procedures.
- Responsible for review and analysis of all manufacturing and analytical data.
- Minimum of 3-4 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment. 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.
- Associate degree or bachelor’s degree in Occupational Health & Safety, Safety Management, or related field is preferred.
- Strong working knowledge of OSHA 29 CFR 1910 is required.
- Up to 3-4 years of work experience in a recent role that involved implementing EHS policies, procedures, and programs to meet the compliance demands of OSHA and NJDEP in a manufacturing setting.
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