5.0 - 9.0 years

0 Lacs

uttar pradesh

On-site

As the QA Oversight Specialist for R&D third parties involved in GMP Manufacturing processes at GSK, your primary role is to ensure the adequate Quality Assurance of services provided by external third-party providers. You will be responsible for managing the Third Party Quality Process to guarantee compliance with GSK quality requirements, cGMP, and regulatory standards. Your duties will include overseeing the release of batches and data in accordance with GMPs and regulatory requirements. Key responsibilities include developing effective processes and procedures in R&D Third Party Quality, contributing to business processes, and providing guidance on quality and compliance policies. You will act as the primary quality contact for assigned third parties or projects, ensuring they operate in alignment with GSK standards. Additionally, you will manage quality governance meetings, handle quality contracts, and oversee deviations, change controls, and validations related to third parties. You will actively participate in the selection and approval of third parties, manage approval statuses, identify and mitigate risks, review documentation for batch release processes, and ensure proper documentation management according to GSK requirements. Collaboration in third-party audit organization, preparation, and execution may also be required, along with participation in product/process transfer teams. In terms of Health and Safety, you will ensure that housekeeping and safety standards are maintained at high levels and that all activities adhere to relevant legislation, GSK safety documents, and local procedures. Qualifications/Requirements: Basic Qualifications: - Bachelor's Degree in Pharmacy, Science, or an engineering discipline, OR equivalent knowledge and experience in Good Manufacturing Practices in the pharmaceutical industry - 5 years of Manufacturing/Quality experience in the Pharmaceutical sector - Familiarity with Quality Systems application in manufacturing, warehousing, and distribution Preferred Qualifications: - Experience working with multi-functional teams - Ability to work independently and prioritize tasks effectively - Strong communication skills, both oral and written - Excellent interpersonal skills to facilitate change and drive initiatives - Proficiency in problem identification and resolution If you possess the required skills and experience and are looking to contribute to a dynamic team focused on ensuring quality and compliance in GMP Manufacturing processes, we encourage you to apply for this role.,

Posted 1 week ago

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