Overview
Quality R&D Third Party Lead Jobs in Belthra Road, Uttar Pradesh, India at GSK
Title: Quality R&D Third Party Lead
Company: GSK
Location: Belthra Road, Uttar Pradesh, India
Role Purpose 职位目标
Ensure QA oversight of R&D third parties involved in the GMP Manufacturing (API, DS, DP) processes.
Responsible for managing Third Party Quality Process that will ensure an adequate Quality Assurance of the services provided to GSK R&D,
Ensure GSK External third party providers of critical services (CMOs) comply with GSK quality requirements, cGMP and regulatory requirements,
Ensure the release of batches / data provided are in compliance with the GMPs and regulatory requirements.
Key Accountabilities/Responsibilities
主要工作职责
Develop and incorporate effective processes and procedures in R&D Third Party Quality and may contribute to business processes and procedures outside R&D Third Party Quality.
Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices.
Act as primary quality contact for the group of third parties or projects he/she is responsible for and for the internal stakeholders involved in activities contracted to these third parties. Monitor and manage the quality performance of these third parties, and ensure they operate in compliance with GSK standards and requirements.
Organize and manage the quality governance meetings for these third parties.
Write, coordinate and ensure the follow-up of the quality contracts approval and update, when necessary.
Ensure complaints, deviations, change control, CAPAs, validations related to third parties are handled in a timely manner and in compliance with cGMPs and Quality Contracts.
Contribute actively in the third parties selection and approval process, as appropriate. Manage the approval status of these third parties.
Ensure Issues and Risks are adequately identified, assessed, mitigated and escalated.
Review and approve all the required documentation for the batch release process.
Ensure all the documentation related to these third parties is correctly reviewed, managed and archived according to GSK requirements.
Collaborate in third parties audit organization, preparation and execution, as appropriate.
Be part of the transfer team for product/process transferred from GSK to a third party and from a third party to GSK.
Health And Safety
Ensure that good levels of housekeeping and safety standards are met and that all activities are carried out in accordance with relevant legislation, GSK safety documents, and local procedures.
Qualifications/Requirements (Education / Experience / Competencies)
申请资格 / 职位要求 (教育背景 / 工作经验 / 知识与技能)
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s Degree in Pharmacy, Science, or an engineering discipline, OR equivalent level of knowledge, understanding and hand on experience of Good Manufacturing Practices in the pharmaceutical environment (CONFIRM WITH MANAGER).
5 years of Manufacturing/Quality experience in the Pharmaceutical industry.
Experience with the application of Quality Systems in manufacturing, warehousing and distribution.
Preferred Qualifications
If you have the following characteristics, it would be a plus:
Experience of working with multi-functional teams.
Ability to work independently and prioritize workload.
Excellent oral and written communication skills.
Strong interpersonal skills with an ability to enable and drive change.
Problem identification and solving skills.
