- Genentech (Oceanside, CA)
- …the support of Product Transfers and Make/Assess/Release in a 24x7 Good Manufacturing Practice ( GMP ) environment. As part of the Site Team and larger Global IT OT ... alerts and logs. + Support virtualization (VMware) and system redundancy for critical GMP applications. **Compliance & Validation** + Ensure systems meet GxP and FDA… more
- PCI Pharma Services (Bedford, NH)
- …heating, ventilation, and air conditioning HVAC, plumbing, etc.) for GMP facilities, utilities equipment, laboratories, warehouse and buildings. **ESSENTIAL DUTIES ... + Operate, maintain, and monitor all equipment utilities systems that supply GMP manufacturing. + Perform preventative, routine, and non-routine maintenance on … more
- Dairy Farmers of America (Houston, TX)
- …the same condition as they arrive + Follow all DFA good manufacturing practices ( GMP ) and work in a manner consistent with all corporate regulatory, food safety, ... judgment + Adhere to all DFA Quality, Safety and GMP policies and procedures and report any nonconformity +...Attend required training, including but not limited to, Safety, GMP , Hazard Analysis and Critical Control Point (HACCP), and… more
- Lilly (Durham, NC)
- …QA Floor Support Supervisor. Responsibilities include providing QA oversight to GMP operations in the Parenteral equipment preparation, formulation, filling, and ... presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs and quality systems. + Reviews and approves... programs and quality systems. + Reviews and approves GMP documentation in support of daily operations such as:… more
- PCI Pharma Services (Madison, WI)
- …I - Operations** , where you'll be on the front lines of GMP production-supporting real-time quality oversight, solving problems as they arise, and ensuring that ... floor: observe critical operations, audit procedures, and monitor compliance during GMP manufacturing + Perform in-process reviews of executed batch records and… more
- Astellas Pharma (Westborough, MA)
- …and industry best practices. The Validation Manager will ensure that all critical GMP equipment and systems are validated and maintained in compliance with user ... Global Validation Strategy for the organization, ensuring all steps of the GMP organization remain compliant with Astellas procedures and domestic / international … more
- Lilly (Indianapolis, IN)
- …and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant ... and resilience as the site grows to a full scale GMP manufacturing through start up. **Responsibilities** Key Objectives/Deliverables: + Technical Leadership… more
- ThermoFisher Scientific (Allentown, PA)
- …(Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail ... that are based on sound quality/compliance principles and appropriate GMP Regulations. **A Day in the Life:** + Apply...changes to facilities and equipment. + Review and Approve GMP documents to ensure compliance with all applicable internal… more
- Genentech (Hillsboro, OR)
- …Quality Assurance, Engineering, and other Customers and Suppliers. + You will ensure GMP -compliant validation practices according to PQS, EU GMP Annex 1, and ... a minimum of 8+ years experience in a sterile GMP environment; Masters Degree is preferred. + You have...familiarity with regulatory guidelines (ISO 13408-1, PIC/S, FDA, EU GMP Annex 1) + You have experience planning, executing,… more
- Lilly (Indianapolis, IN)
- …and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant ... creativity and resilience as the site grows to a full scale GMP manufacturing through start up. **Job Position Overview:** The Supervisor provides leadership… more
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