- ThermoFisher Scientific (Fair Lawn, NJ)
- …steps based on risk -based approach. + Provide expert mentorship on risk management , vendor qualification, and statistical process control. + Design, plan ... Assurance, or Quality Control position within the Chemical, Medical Device or Pharmaceutical , or highly regulated Industries supporting Regulated Products. + 5 years… more
- Integra LifeSciences (Plainsboro, NJ)
- …operations. These projects are typically of increased complexity and can pose significant risk to product and processes if not designed and implemented correctly. + ... Product Development, Marketing, QA, and Clinical & Regulatory Affairs. + Project Management aimed to evaluate, analyze, and improve existing processes, support the… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …technology and process redesign that drive revenue growth, cost optimization, risk mitigation, and enhanced compliance + Develop purposeful investment roadmaps with ... roadmaps + Oversee program/project execution including solution delivery, stakeholder management , communication, change management , and value realization +… more
- Church & Dwight Co., Inc. (Princeton, NJ)
- …implementation of a technical QMS area CAPA) of Church & Dwight's global Quality Management System for all Church & Dwight sites globally. The position ensures all ... and compliance. This position is responsible for influencing all levels of management , including the ELT, of business needs to ensure an appropriate level… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …procedures to be documented and set up. Establish the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements + Review ... to conduct detail evaluation of risks / identify potential risk areas. Review existing products for safety risks and...10+ years in PV & Medical Affairs in the pharmaceutical industry **Skills & attributes:** + Understanding of North… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …of IT risks, controls, audit, and compliance frameworks within a global pharmaceutical or highly regulated environment. Essential Functions: + Oversee the global IT ... SOX program lifecycle, including risk assessment, scoping, control design, testing coordination, deficiency tracking, and remediation planning. + Serve as the… more
- Sokol Materials & Services (Skillman, NJ)
- …a highly dynamic environment. + Basic knowledge of quality by design and risk management . + Basic experience with Operational Excellence and Lean Manufacturing ... tech transfer, and validation . + Design and execute test plans and other risk mitigation exercise as part of investigations (eg Root cause analysis and CAPAs). +… more
- Astrix Technology (Monmouth County, NJ)
- …review pharmacovigilance documents including: + Periodic Safety Update Reports (PSURs/PBRERs) + Risk Management Plans (RMPs) + Development Safety Update Reports ... join us! Our partners range from emerging biotech firms to established pharmaceutical companies. Opportunities are available both remotely and on-site throughout the… more
- Sokol Materials & Services (Skillman, NJ)
- …a highly dynamic environment. + Basic knowledge of quality by design and risk management . + Basic experience with Operational Excellence and Lean Manufacturing ... tech transfer, and validation . + Design and execute test plans and other risk mitigation exercise as part of investigations (eg Root cause analysis and CAPAs). +… more
- Sokol Materials & Services (Skillman, NJ)
- …or ISPE. + Prior experience of QC equipment Qualification and some project management experience. + Knowledge of biotech, bulk drug substance or finished product ... Operating Procedures (SOPs). * Review and approve validation documents including risk assessments, protocols, test scripts, and summary reports. * Review and… more