Glaxo Smith Kline Work Values

Daily Duties at Glaxo Smith Kline:

Responsible for overseeing daily activities related to planned change controls, including changes to equipment, processes, suppliers, SOPs, specifications, methods, batch records and other applicable documentation. Ensures timely processing, accuracy and compliance for Contract Manufacturing changes that impact GSK products produced and distributed in the U.S. and Global Markets. Lead negotiation efforts to ensure resolution to change control issues that affects product quality and supply. Communicates on an ongoing basis with Contract Quality Managers to ensure that potential quality issues are identified. Interfaces with other change control staff at international and domestic sites to develop positive relationships. Utilizes SAP database to manage change control project activities. Conducts pre-assessments of change requests to evaluate the impact of the change. Conducts an evaluation and assessment of Change Requests to insure that the distribution for approvals/advice/notification are correct and are processed in a timely manner. Ensure that all changes are processed in accordance with site procedures/SOP’s and Global Policies (GQMP, GQP). Audit Change Control files to ensure that required documentation is present prior to file closure. Conduct routine follow-up to change control files to ensure prompt and accurate closure to proposed changes. Provide Change Control recommendations to local and global GSK sites concerning change control issues and continuous improvement. Participate in FDA and internal audits concerning change control procedures. Initiates and develop change control strategies to insure that changes are facilitated with no adverse impact to product supply, quality, and compliance. Create system to insure quick retrieval of documents required during FDA and internal audits. Provide support documentation associated with change control to Regulatory for products and drug substances which impact registration. Assemble and review Change Control Annual Reportable data which result from implemented changes for inclusion in the FDA Annual Report. Prepare reports for submission to Post Approval Regulatory Affairs. Research and update Product Specifications as required for maintaining compliance with registered details. Review regulatory documentation and initiate change controls for regulatory mandates. Prepare monthly Change Control metrics for management review.

What they like about Glaxo Smith Kline:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

quality manager, validation, pharmaceutical, CAPA, change control, Quality Engineer, Quality Assurance, Investigation, GCMS, Documentum, Quality, training, specialist, Clinical, operations

Skills

Change Control, Document Control Management, Training System Management, Validation, CAPA, Quality Engineering, Pharmaceutical Quality, Quality Assurance, product quality deficiency investigation, Consulting

These are some of the questions we asked our climbers about their experiences with Glaxo Smith Kline: