Validation Support Specialist
GlaxoSmithKline - Worthing

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Basic qualifications:

Education
• Secondary school education with relevant industrial experience
• Secondary pharmaceutical tablet manufacturing and packaging, powder manufacturing, bottle filling and packaging equipment
Job Related SKills
• Pharmaceutical experience in technical, validation or quality role.
• Knowledge/awareness of external regulatory (MHRA, FDA) requirements.
• Experience in presenting to Regulatory Authorities (MHRA, FDA) and senior management
Other
• Knowledge of Orals Value Stream Processes
• Knowledge of Validation Lifecycle.
• Computer Systems Validation Awareness
• Good knowledge of site safety regulations
• Knowledge of audit processes, preparation and requirements
• Computer Skills – Excel/PowerPoint/Word.
• Ability to plan, organise and control workloads of self and others to meet deadlines and deliver schedule and targets.
• Ability to make decisions in a timely manner.
• Good working knowledge of GSK Worthing site systems, e.g. SAP, Change Control, Novamanage etc.
• Strong written and verbal communication skills
• Excellent attention to detail
Preferred qualifications:
• Degree and/or a demonstrated track record in the Pharmaceutical Industry in a technical role.
• Chemistry or Chemical Engineering
Details:
To enable people to do more, feel better, live longer by consistently delivering outstanding quality, service and value to our patients and consumers, through a best-in-class, integrated supply chain.
Responsible for maintaining the validation status in Secondary Orals Production Operations, ensuring the appropriate level of technical knowledge and understanding is available to meet the business demands. This will be achieved through continued development of technical competency and improvements to regulatory compliance for our processes, equipment and facilities.
Success will be demonstrated through improving Key Performance Indicators for EHS, Quality, Compliance, development of a capable and competent team and improving Cost of Goods (COGs) through reducing appropriate process cost per unit measures.
• EHS/ Zero Accidents
o Execute activities in accordance with all EHS & Quality standards, systems and procedures, including all relevant statutory, regulatory and GSK frameworks
o Operate a zero tolerance approach towards unsafe activities to drive a Zero Accident operation.
• Quality/ Zero Defects
o Ensure all activities undertaken by you are in accordance with statutory, regulatory and company cGMP, Engineering and Technical standards, procedures and systems.
o Apply a Right First Time approach for services provided to deliver a Zero Defect operation.
• Operational Excellence/Zero Waste
o Utilise Operational Excellence tools and techniques to optimise the service standard and delivery performance to meet the business objectives.
o Identify improvement opportunities to deliver a Zero Waste performance.
• Deliver Products of Value at Optimal Cost
o Maintenance of existing validation status by review, revalidation and verification
o Write Validation Documentation and execute planned activities on time and in full.
o Identify compliance and efficiency opportunities to improve the Orals Value Stream performance that support the strategic intent.
o Provide subject matter expertise for the Orals Values Stream for validation maintenance activities.
• Team/ Investing in our Winning Team
o Use relevant training options to take personal responsibility to increase competencies and knowledge of self.
o Build, develop and sustain the knowledge, capability and competency within technology areas to meet business objectives.
o Work to and demonstrate the GSK Values and Behaviors.
o Ensure all project areas are fully resourced and effectively escalate issues to line manager and support resolution.
• Connect across GSK to Drive Performance
o Build and maintain effective working relationships with Operations, Technical, Engineering and Quality teams.
o Build, develop and maintain relationships with other sites and above site groups.
o Build knowledge of content of existing Validation documentation
Breadth/ Scope of Accountability*
Provide details of any scope data relevant to the role e.g. the net sales that the role supports / generates or budget responsibility.
Closing date for applications: 13th May 2014
When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.
Thank you for your interest in this opportunity.
*LI-GSK
Contact information:
You may apply for this position online by selecting the Apply now button.
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Formed after the merger of GlaxoWellcome plc and SmithKline Beecham plc in 2000, GlaxoSmithKline plc (GSK) is a global pharmaceutical,...