4 Quality Investigations Jobs

The work you do every day at Illumina can have a profound impact on the lives of people globally. As part of a team dedicated to expanding access to genomic technology, you will contribute to the realization of health equity for billions of individuals. By enabling life-changing discoveries that improve human health through early disease detection, diagnosis, and innovative treatment options, you will play a crucial role in transforming healthcare for the better. Working at Illumina means being part of a larger mission that goes beyond individual contributions. Regardless of your role, you will have the opportunity to make a difference and grow professionally. Surrounded by exceptional colleagues, visionary leaders, and groundbreaking projects, you will push your boundaries and achieve more than you ever imagined possible. This position is pivotal in overseeing Supplier Quality activities at Illumina, ensuring compliance with Quality System Regulations, company policies, FDA regulations, and ISO standards. By monitoring and enhancing Illumina's product quality and collaborating with suppliers, this role plays a crucial part in achieving operational objectives and driving continuous improvement initiatives. Responsibilities include qualifying, evaluating, and monitoring new suppliers and partners for Illumina products and services. Collaborating with cross-functional teams, you will coach partner processes and contribute to new product development and quality assurance efforts. By driving process and product improvements through supplier development activities and quality investigations, you will play a key role in maintaining high standards. Additionally, you will lead Quality Investigations and CAPA/SCARs to resolve quality issues, conduct supplier audits, and support global initiatives for supplier performance reviews. Your expertise will be crucial in ensuring compliance, driving process standardization, and resolving issues effectively. To excel in this role, you should have experience working with cross-functional teams, strong QMS auditing skills, and proficiency in Quality Management Systems and process engineering methodologies. Experience with non-conformance handling, failure investigation, and risk management activities is essential. Strong communication, negotiation, and project management skills are also required to succeed in this dynamic and fast-paced environment. Travel may be required, both domestically and internationally, to collaborate with teams and partners effectively. While the listed requirements are essential functions of the position, accommodations may be made based on business needs to accommodate additional tasks and responsibilities. In terms of qualifications, a technical discipline background with a Bachelor's, Master's, or PhD degree, along with relevant experience, is necessary. Experience in a regulated environment, particularly in in-vitro diagnostics, is preferred. Practical experience with FDA and ISO regulations, statistical analysis, and electronic product life cycle systems is advantageous for this role.,

We are looking for an innovative and experienced quality analyst to join our team. The quality analyst is responsible for developing and supporting the planning, design, and execution of test plans, test scripts, and process plans for projects. The successful candidate will work closely with various departments to perform and validate test cases based on quality requirements, and recommend changes to predetermined quality guidelines. You will be responsible for ensuring that the end product meets the minimum quality standards, is fully functional and user-friendly. To be successful as a quality analyst, you should demonstrate strong attention to detail and have analytical and problem-solving abilities. The ideal candidate must be able to interpret and implement quality assurance standards and provide accurate and comprehensive feedback to colleagues. Quality Analyst Responsibilities: Develop and execute test plans to ensure that all objectives are met. Implement and monitor test scripts to assess functionality, reliability, performance, and quality of the service or product. Identify and remedy defects within the production process. Recommend, implement, and monitor preventative and corrective actions to ensure that quality assurance standards are achieved. Compile and analyze statistical data. Ensure that user expectations are met during the testing process. Draft quality assurance policies and procedures. Investigate customer complaints and product issues. Ensure ongoing compliance with quality and industry regulatory requirements. Quality Analyst Requirements: A bachelor's degree in computer science, information systems or a related field. Experience in quality inspection, auditing, and testing. Excellent communication skills, both written and verbal. Strong computer skills and knowledge of QA databases and applications. Strong analytical and problem-solving skills. Meticulous attention to detail.

You will be working at Piramal Pharma Solutions in the Engineering & Projects Department located in Digwal, Hyderabad. The role involves extensive travel. Your main responsibility will be managing projects from start to finish, ensuring design, budgeting, vendor management, and execution are done efficiently and cost-effectively. It is crucial to comply with GMP, ISO 14001, OHSAS 18001, and other regulatory standards. You will oversee commissioning, validation, and operational readiness of facilities and equipment, as well as manage safety and environmental risks by implementing robust SHE practices. Continuous improvement through risk assessments, CAPA, and comprehensive training for teams and contractors is also part of your role. You will report directly to the Site Head and oversee a team of 6-8 individuals. The ideal candidate should have at least 15 years of experience in Manufacturing, GMP, Safety, and resolving technical customer queries. Good communication skills are essential. Competencies required for this role include QMS handling, understanding changing regulatory requirements, confidence in facing audits, team management, quality investigations, analytical knowledge, collaborating with CFTs, and being the SPOC for CDMO projects. Your key responsibilities will include identifying, evaluating, and implementing projects on time and within budget, designing facilities, identifying vendors and contractors, inspecting equipment and project materials, issuing specifications and drawings, commissioning projects, validating facilities, ensuring compliance with ISO14001:2004 and OHSAS 18001:1999, identifying risks and hazards, developing objectives, targets, and programs under EMS & OHSMS, monitoring operational controls, conducting root cause analysis, ensuring continual improvement in OHS & EMS Management Systems, identifying SHE training needs, and ensuring SHE requirements related to contracted services and service providers are met. The ideal candidate should hold a B-tech degree (any stream). Piramal Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO) providing end-to-end development and manufacturing solutions across the drug life cycle. The organization values inclusive growth, ethical practices, and equal employment opportunity based on merit. If you are looking for a challenging role in a dynamic environment, this opportunity at Piramal Pharma Solutions could be the right fit for you.,

As the Project Manager within Piramal Pharma Solutions" Engineering & Projects department based in Digwal, Hyderabad, you will have the overarching responsibility of managing projects from start to finish. This includes tasks such as design, budgeting, vendor coordination, and ensuring timely completion within optimal costs. Your role will involve ensuring compliance with various regulatory standards such as GMP, ISO 14001, and OHSAS 18001. Additionally, you will lead the commissioning, validation, and operational readiness of facilities and equipment, while proactively managing safety and environmental risks by implementing robust SHE practices. Continual improvement will be a key focus, achieved through risk assessments, CAPA implementation, and providing comprehensive training to both internal teams and contractors. Reporting directly to the Site Head, you will oversee a team of 6-8 individuals. To excel in this role, you are expected to bring at least 15 years of experience in Manufacturing, GMP, Safety, and resolving technical customer queries. Strong communication skills are essential for effective collaboration with various stakeholders. Key competencies required for this position include QMS handling, understanding changing regulatory requirements, confidence in facing audits, team management, conducting quality investigations, possessing analytical knowledge, collaborating with cross-functional teams (CFTs), and serving as the Single Point of Contact (SPOC) for CDMO projects. Your main responsibilities will revolve around the identification, evaluation, and implementation of projects within set timelines and budgets. This will involve designing facilities, selecting vendors and contractors, inspecting equipment and materials, issuing specifications and drawings, evaluating project progress, preparing budgets and schedules, overseeing project commissioning, validating facilities, and ensuring compliance with ISO14001:2004 and OHSAS 18001:1999 requirements. You will also be responsible for identifying risks and hazards, developing objectives and targets under EMS & OHSMS, implementing operational controls, conducting root cause analysis for non-conformities, and driving continual improvement in OHS & EMS Management Systems. Additionally, identifying SHE training needs, ensuring SHE requirements with contracted services and providers, and maintaining a focus on safety and environmental practices will be crucial aspects of your role.,