- Possession of a bachelor's degree plus 2 years of experience with Microsoft Office applications, validation, project management, quality management systems, and GMP industry
- Ability to work on assignments that are complex in nature, in which independent action and a high degree of initiative are required in resolving problems and developing recommendations
- Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities
- Demonstrated problem solving and investigational skills
- The ability to communicate both verbally and in writing with all levels both inside and outside of the organization
- The ability to clearly write technical documentation as necessitated by regulatory agencies and internal policy
- Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes
- Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production, EHS and QA. Ability to work in a highly complex matrix environment
- Able to prioritize and decide appropriate course of actions and to effectively implement decisions
- Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions
- Must operate cross-functionally and be able to lead in a matrix organization
- Sense of urgency, flexibility and accountability.
- High level of computer skills required
- Maintain current on developments in the field and according to GSK Standards
- Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines
- Maintain a high level of integrity while balancing multiple priorities and responsibilities
- Possession of a bachelor's degree plus 5 years of experience with Microsoft Office applications, validation, project management, quality management systems, and GMP industry
- Knowledge of GMP's, NIH Guidelines, FDA, OSHA and other regulatory agency requirements sufficient to apply to quality and safety operations and compliance
- Technical & Engineering Experience
Responsible for providing technical, compliance and organizational support to management of Technical Services operations through planning, scheduling, QMS compliance, risk and change management. Comply with instructions on standard operating procedures and batch documents. Ensures schedule adherence to meet GMP compliance. Actively promotes the success of the VS through continual collaboration with the team. Champions the voice of the customer in decisions affecting Technical Services resource allocation and project prioritization.
Environment Health & Safety: Responsible for application of GSK safety and environmental guidelines. Promotes a safety culture; perform work in a manner to ensure safety of co-workers, equipment and self.
Quality & Compliance: Ensures all activities are executed following quality and regulatory standards. Promotes a quality mindset and quality excellence approach to all activities. Revises SOPs as assigned. Complies with SOP, Batch Record and Departmental Documentation requirements. Completes and/or attends all mandatory training and maintains training forms and files. Adhere to all GSK Quality Management System (QMS) policies and procedures as applicable for functional area.
Accountability: Ability to manage multiple projects and tasks in order to achieve deliverables and adhere to timelines and budgets. Ensures efficient coordination of projects and tasks as assigned by supervisor. Proactively keep process owners and supervisor informed of progress and activities. Deal positively with change, demonstrating the ability to maintain high personal performance levels as the organization evolves.
Continuous Improvement: Proactively identify opportunities for process improvements and presents ideas to process owner, Lead or Supervisor. Assist in monitoring and reporting of KPI's and metrics.
- Drive individual performance and accountability
- Responsible for ensuring that scheduled work is performed on time in an appropriate manner as per GSK procedures and guidelines
- Escalate issues that could present a cGMP noncompliance or an unsafe work environment.
The following HPB's are key behavioral characteristics for this job role:
- Continuous Improvement: Drives and leads change through others by constantly examining existing processes and systems to determine more efficient and improved ways to do things. Establish a proactive culture within the facilities and maintenance group looking forward for solutions.
- Flexible Thinking: Delivers results by analyzing situations to determine the best solution for issues at hand. Able to think creatively to and strategically to accomplish what is best for the department, site and organization.
- Enable and Drive Change: Adept in determining technical solutions for problems and issues and leveraging relationships and influencing others to the desired way of thinking. Ability to bridge gap between technical and non-technical arenas.
- Support deviation investigations, gathering data on equipment/facility problems and implementing lean and 6-sigma tools, such as DMAIC, 5 whys, FMEA, cause & effect diagrams, and document results in reports, in order to identify the cause of the problem.
- Participate as member of cross functional team to investigate deviations.
- Lead investigations, draft investigation reports
- Provide timely escalation of complex and difficult problem solving issues to cross-functional teams for investigation
- Promote successful site change management through support of Change control for Technical Services.
- Attend weekly PMT meetings
- Create and maintain project plans for TS change controls/projects.
- Deliver successful site planning through project management of departmental Capex projects
- Assist with departmental project prioritization through project management techniques and technical support and cross functional collaboration.
Spare Parts Master Data Management Support
- Create and manage SAP Spare Part Master Data in SAP production and development systems including development of Bills of Materials (BOMs)
- Ongoing and periodic maintenance of Spare Part master data to ensure data integrity and uniformity to improve Master Data processes and monitoring
- Support Effectively manage inventory levels to meet budget guidelines
- Ability to report on SAP Spare Part Master Data, regularly and on an ad hoc basis in support of KPIs
TS Compliance Support
- Support SAP implementation and upgrade projects
- Assist with departmental project prioritization through project management techniques, technical support and contractor coordination
- Develop, author and modify departmental LSOP's as needed in support of daily operations and implement OE initiatives within primary area of responsibility.
- Ensure compliance to GSK policies and procedures for the management of the Technical Service department for facilities and equipment.
- Compliance to good documentation practices and "right the first time".
- Escalate issues that could present a cGMP noncompliance or an unsafe work environment.
- Follow defined methodology and standards including preparation, review and maintenance of GMP documentation for all stages of work.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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