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The Sr Compliance Specialist in R&D is responsible for ensuring compliance with internal SOPs, company policies, and cGMP requirements in the Research and Development department. They review stability summaries, method validation reports, cGMP protocols, controlled documents, and assist in audits and investigations. The role also involves representing Quality in project teams, performing internal audits, and supporting regulatory inspections.
The Medical Device Quality Management System (QMS) Project Manager is responsible for planning, executing, and overseeing projects related to the development, enhancement, and maintenance of the Quality Management System (QMS) in compliance with regulatory standards. This role requires strong project management skills to ensure that QMS initiatives are completed on time, within scope, and in alignment with organizational objectives. The QMS Project Manager will work closely with cross-functional teams, including quality assurance, regulatory affairs, product development, and manufacturing, to drive continuous improvement in quality processes and ensure regulatory compliance.
The Strategy Project Manager will lead development of strategic initiatives to improve the efficiency and growth ambitions of the generics business, manage multidisciplinary teams, deliver financial analysis, define project scopes, resolve risks, lead change management, and ensure compliance with company standards.
Oversee document management and training for medical device design, development, and manufacturing processes. Develop and maintain document management system, create training programs, ensure regulatory compliance, lead team collaboration, and drive continuous improvement initiatives.
Managing implementation of projects related to the manufacturing of terminal sterilized pharmaceutical bags, providing process analysis, executing process improvement ideas, managing process improvement projects, and supporting operations and quality teams.
The Associate Technical Writer is responsible for investigating deviations, customer complaints, and writing documents. Responsibilities include implementing change controls, cost improvement initiatives, and new product introductions. Requires a Bachelor's degree, advanced critical thinking, and 1-2 years of experience in GMP manufacturing environment. Familiarity with FDA regulatory requirements is necessary. Excellent salary and benefits are offered.
Analyzing and executing processes to ensure product quality in the Production Unit. Providing Quality support for product development initiatives and manufacturing operations. Initiating and managing CAPA records. Supporting internal and external audits. Compiling and analyzing quality metrics. Ensuring regulatory compliance and upholding the Quality Management System. Collaborating with cross-functional teams on daily tasks and projects.
Responsible for operating and troubleshooting high-speed IV bag filling line, conducting in-process control testing, and promoting teamwork through communication. Must have 3+ years of pharmaceutical experience and be adept at problem-solving in a clean room environment.
Experienced software solution architect with a background in Pharma, Bio-Tech, or Medical Device industries. Responsibilities include interpreting business requirements, architecting solutions, providing technical assessments, and working with internal teams and software vendors. Requires 5+ years of experience in API, Web Service, third-party integrations, and Life Sciences business processes. Proficiency in Apriso MES, ERP (SAP), Azure DevOps, JIRA, confluence, and Azure cloud environments. Familiarity with Agile Methodology.
The Full Stack Senior Software Engineer will enhance web application user interfaces, services, and data model while influencing the current product and developing the next generation. Responsibilities include technical leadership, code reviews, resolving software defects, and mentoring junior staff. Requirements include a Bachelor's degree in Computer Science with 8-10 years of experience, Agile environment experience, software product development experience, and proficiency in C# and related technologies.
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