Team Leader MicroBiology, Open to flexible working
GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
We have a vacancy within our platform operations QC team.
Key Responsibilities include, but are not limited to:
- Provide specialist microbiological knowledge, expertise and troubleshooting skills for internal CGT process and processes contracted out to third parties.
- Implement and maintain GMP compliant SOPs and instructions aligned with regulatory expectations for microbiological testing of CGT materials and facilities including rapid sterility, bioburden, mycoplasma and endotoxin testing and environmental monitoring
- Perform trend analysis of microbiological test results and quality indicators for sterility testing, bioburden testing, mycoplasma testing, endotoxin testing and environmental monitoring and raise and investigate any quality risks.
- Ensure microbiological test and associated equipment are validated and maintained in line with GSK QMS and regulatory expectations
- Ensure change controls, quality deviations, atypical / out of specification results and quality / business risks associated with area of responsibility are appropriately escalated, investigated and take ownership for the delivery of any required actions.
- Author and review standard operating procedures and analytical instructions as necessary.
- Author or review analytical data and commentary for regulatory submissions as required.
- Represent Quality Control during internal audits and regulatory inspections for area of responsibility.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV 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.
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.
We are looking for professionals with these required skills to achieve our goals:
- BSc or MSc in Microbiology or similar discipline with expert knowledge of environmental monitoring and sterility testing.
- In depth understanding of Microbiological testing.
- Previous experience in a similar microbiology role within a GMP regulated environment.
- Experience in supervisory is essential.
- The ability to apply GMP principles to working in a Quality Control laboratory.
- Designing and implementing local quality control systems and processes.
- Performance Qualification of Analytical methods.
If you have the following characteristics, it would be a plus:
- Strong organisational and communication skills.
- Demonstrable ability to work independently, to plan and carry out the tasks required to manage responsibilities and complete objectives.
- Outstanding written, verbal and interpersonal communication skills.
- Ability to work with matrix teams to ensure execution of deliverable successfully.
- Demonstrated problem solving abilities.
- Ability to effectively communicate complex and technical information and influence stakeholders and technical staff.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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