Orals Shift Operational Quality Advisor, Open to flexibility
Orals Shift Operational Quality Advisor, Open to flexibility
We have a fantastic opportunity for an Operational Quality Advisor (QA) to join our Orals team on site at GSK Worthing where you will be working as part of our shift team.
About the site:
At Worthing, our focus is to manufacture and supply the broad-spectrum antibiotic, Augmentin as oral tablets, suspensions and sterile injectable dose forms. The site has a complex operation with two orals manufacturing areas, two packing areas with 12 lines, a bulk sterile manufacturing plant and vial filling lines. There has been significant recent investment in the site including a new £120m bulk sterile facility due to come on line in 2019.
What will the role look like?
You will be the first line of contact for operational quality advice and support for Production and other site areas. You will be key in driving early detection and help prevent potential quality issues. You will be responsible for driving adoption and embedding of Root Cause Analysis (RCA)/CAPA processes, and as a member of the Site Quality team, you will be accountable for advising, coaching and mentoring site staff on all relevant aspects of cGMP. You will also be working alongside and supporting as required the day to day Batch Release teams.
Day to Day responsibilities will include:
- Real time review of incidents, issues and events to determine the correct incident categorisation, investigation and Quality approval for Orals Manufacturing and Packaging departments
- Use GSK Production System (GPS) process tools such as GEMBA / Process Confirmation / 5S techniques to review and identify weaknesses and recommend improvements within Quality and Orals Manufacturing and Packaging processes.
- Mentoring and coaching of shift operators, supervisors and engineering craftsmen and technical colleagues in all relevant aspects of GMP
- Ensuring robust communication and escalation of Orals Value Stream (OVS) Quality, Safety and Compliance issues to QA and OVS Management Teams.
- Provide Quality oversight and Real time in use support for planned, unplanned changes and engineering interventions in the OVS.
- Review and approve documents as the Quality representative such as Standard Operating Procedures (SOPs) and technical reports. Support Validation document review and understand the impacts of change control in the area.
- Support training activities of all shift manufacturing personnel for items such as GMP or other Quality Related site mandated training
- Become and expert and understand the GSK Quality Management Systems (QMS) and its application to Worthing processes, and understanding of the regulatory requirements for the area(s) being supported.
- Review and verdict documents from all production areas for bulk and intermediate product release while maintaining an efficient service in line with customer demands for the release of manufactured batches as required.
You will be a flexible, highly motivated and experience Quality professional seeking a new opportunity to develop and grow your skills within a talented team. The ability to work in and lead cross functional teams. You will have experience of the Pharmaceutical industry and a strong understanding of current GMP and technical processes. You should have a good knowledge of deviation management and regulatory requirements as well as knowledge and understanding of laboratory testing including out of specification investigations.
You will be organised and possess strong attention to detail and can function in an atmosphere of constant change with detailed accuracy. You will also have excellent communications and interpersonal skills at all levels both written and verbal.
Interested in Applying?
Please note this role will be based at our site in Worthing, West Sussex, and will be working on the sites 24/7 shift pattern - two days, two nights (each 12.25 hours), 4 off - rolling shift pattern.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Closing date for applications: COB - Tuesday 13th November 2018
When applying for this role, please use the 'cover letter' of the on-line application to 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 and CV will be used to assess your application.
Thank you for your interest in this opportunity.
You will possess A level or equivalent level of qualification in Science and Maths as well as have equivalent experience within a Quality focused role.
In addition you will also possess:
- Experience in a pharmaceutical manufacturing organisation
- Experience of aseptic manufacturing
- An understanding of current GMP and technical processes is required.
- The ability to work in and lead cross functional teams.
- Good organisation and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy.
- Excellent communications and interpersonal skills at all levels both written and verbal. Good computer skills.
- Understanding and ability to demonstrate use of continuous improvement techniques.
- Knowledge of deviation management and regulatory requirements.
- Knowledge and understanding of laboratory testing including out of specification investigations.
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on GSK please refer to our website: www.gsk.com
WHAT DO WE OFFER?
At GSK we are all inspired by the difference we make and challenge ourselves every day to improve the lives of patients and consumers. That's why we have created an environment where everyone feels valued, able to develop, contribute to our mission and be proud of what we achieve.
HOW DO I DEVELOP MY CAREER?
To support you in achieving your role and career ambitions you'll be given the opportunity to:
- Play an important role in delivering our mission
- Be an essential part of diverse, global team
- Develop others as part of your own professional growth
You will also have regular personal development meetings with your line manager to give you the opportunity to create a fulfilling career at GSK.
HOW WILL I BE REWARDED?
The Total Reward Package offered includes:
- Competitive Salary + Shift Allowances
- Competitive on Target Bonus
- 26-days paid holiday
- Personal Healthcare, with the option to purchase family cover
- GSK Pension
- Share & Save Schemes
- Total Reward Discounts
You may apply for this position online by selecting the Apply now button.
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