9 Gxp Standards Jobs

Job Summary The candidate will support MES operations in a pharmaceutical manufacturing environment ensuring compliance with GxP standards and delivering high-quality support and lifecycle management. Responsibilities Need to manage incidents problems and changes in a regulated environment. Need to act as the first line of support monitor application health and perform Root Cause Analysis. Need to create and track change requests execute tasks and perform IQ/OQ testing to ensure compliance.

Area(s) of responsibility Act as Technical Product Owner for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements. Gather, analyze, and document business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness. Manage product backlogs in JIRA, defining clear user stories, acceptance criteria, and prioritization based on business value. Collaborate with development, QA, and regulatory teams to ensure product features meet both technical specifications and regulatory standards. Facilitate workshops, requirement-gathering sessions, and backlog grooming using Confluence for documentation and collabo...

You will join Regeneron, a company dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. Your role will involve supporting cGMP compliance within procurement operations by assisting with various key activities. **Role Overview:** As part of the team, you will be responsible for ensuring successful audit closures, managing Supplier Corrective Action Reports (SCARs), partnering with team members for Quality and Compliance discussions, implementing process efficiency strategies, and contributing to maintaining adherence to regulatory requirements. **Key Responsibilities:** - Proactively address issues to achieve successful audit clo...

About Us: Birlasoft, a global leader at the forefront of Cloud, AI, and Digital technologies, seamlessly blends domain expertise with enterprise solutions. The company's consultative and design-thinking approach empowers societies worldwide, enhancing the efficiency and productivity of businesses. As part of the multibillion-dollar diversified CKA Birla Group, Birlasoft with its 12,000+ professionals, is committed to continuing the Group's 170-year heritage of building sustainable communities. Yrs of exp- 12 -15 yrs Location- Noida Immediate joiners Act as Technical Product Owner for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements. ...

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. We are looking for a motivated individual to support cGMP compliance within procurement operations. In this role, you will assist with key compliance activities such as investigating deviations, supporting CAPAs, coordinating supplier audits, handling change controls, and...

As a Quality Management System (QMS) Specialist, your role will involve establishing, implementing, and continuously improving the company's QMS to support its clinical-stage biopharmaceutical development programs while ensuring compliance with regulatory requirements such as FDA, EMA, ICH, and GxP standards like GMP, GDP, GCP, GLP. Your responsibilities will include: - **QMS Development & Implementation**: - Developing, implementing, and maintaining a phase-appropriate QMS aligned with regulatory requirements. - Establishing, reviewing, and updating Quality System documentation to support GxP operations. - Serving as the system owner for the electronic QMS and ensuring effective document co...

As a motivated individual, you will play a crucial role in supporting cGMP compliance within procurement operations at Regeneron. Your responsibilities will include investigating deviations, supporting CAPAs, coordinating supplier audits, handling change controls, and contributing to the development and implementation of the Supplier Corrective Action Report (SCAR) process. **Role Overview:** You will be essential in ensuring successful audit closures by proactively addressing issues with suppliers and maintaining clear communication to achieve satisfactory outcomes. Additionally, you will manage SCARs, follow up with suppliers and internal team members, and ensure timely reporting and closu...

You will be joining UMEDICA, a vertically integrated company involved in manufacturing and exporting a wide range of finished formulations globally. The company's manufacturing facility in Vapi, Gujarat, is approved by global regulatory authorities. UMEDICA, established in 1983, operates in over 85 countries worldwide, including prominent markets like the USA, Canada, EU, UK, Australia, Middle East, and more. As part of our expansion plans, we are seeking an Assistant Manager / Manager with a strong background in Packaging to join our R&D center in Turbhe, Navi Mumbai. In this role, you will directly report to the Head of Formulation Development. Your responsibilities will include: - Develop...

As a Senior Software Engineer - Front End at Bristol Myers Squibb in Hyderabad, you will play a crucial role in leading and contributing to technical solution design, development, and deployment activities within the Commercialization IT function. Your responsibilities will span across investment projects, operational changes, and innovation projects to support organizational goals. Your key responsibilities will include partnering with Commercialization IT leads and the broader IT matrix organization to design and implement digital capabilities that enhance customer engagement and experience. You will collaborate with IT partners and business teams to understand requirements, align outcomes...