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Job ID :
65060BR
Location :
United Kingdom - Swindon
:
Job Description
About us

ThermoFisher Scientific Swindon is the newest member of the ThermoFisher Scientific Family. With over $20 billion in annual revenue and 65,000 employees worldwide, ThermoFisher Scientific is the place to be for ambitious people.

Here at Swindon, we are a leading Contract Development and GMP Manufacturing Organisation in the field of Sterile Manufacturing. We offer our clients an unrivalled mix of technologies, taking their products from the earliest stages of development through to commercial operations.

Our Swindon operations offers full commercial manufacturing services for sterile liquids, high-potency products, as well as lyophilized vial forms. We champion the ‘Condo Model’ and manufacture speciality products for clients; offering an impressive mix of laboratory, business and production expertise. Because of this unique offering, we are experiencing huge growth as new clients joins us.

About the job

An exciting and challenging opportunity has arisen for a Quality Assurance Team Lead within one of our Condo Facilities.

As the QA Team Lead you will be lead the implementation of the quality systems and related processes from project phase (equipment and process validation) to full cGMP commercialization for one of our Condo clients.

Key Duties and Responsibilities:
Your duties as the QA Team Lead will be varied, however the key duties and responsibilities are as follows:
• Providing Quality Input on the life cycle of Validation documents from URS’s through to PQ’s.
• Working closely with Production and Engineering to ensure new products are manufactured in accordance with cGMP.
• Implementing QA on the shop floor.
• Providing quality and compliance input in reviewing of SOPS, Batch Manufacturing Record Reviews, Change Controls, CAPA’s, Deviations & OOS across departments.
• Managing a team of QA Officers.
• You will work closely with the site Qualified Persons (QPs) ensuring batch release schedules are adhered to.
• Delivering training and continuous improvement around processes to improve quality and compliance
• Conducting internal audits and participating in client, corporate and regulatory audits.
• Providing annual product reviews for our client’s product.
Reporting to the QA Operations Manager, the role will be hands on as well as managerial and will involve astute planning, organization and leadership to meet quality actions for demanding timelines. You will be expected to be integral in championing and establishing robust lean compliant processes at all stages of the project; working closely with the Condo client as a key member of the project management team.

About you

To be successful in your application for this exciting opportunity as the QA Team Lead we are looking to identify the following in your profile and past history:

Qualifications/Experience:

• Minimum Science based degree.
• Leadership and Management experience of a small/medium/or large team.
• Proven industry experience of over 5 years in Quality Assurance working within a Pharmaceutical Manufacturing Organization.
• A working knowledge and practical experience of GMP guidelines.
• Experience of working in a sterile manufacturing facility would be advantageous.
• Involvement in the set-up of a new facility or process would be useful.
• Prior experience with regulatory bodies such as FDA and MHRA is highly desirable.
• Prior experience with Cephalosporin’s would also be an advantage.
We are looking for people who are passionate about making a difference in people’s lives. People who are motivated to do their best for the company, our clients and our patients – and to inspire collaboration and innovation.

In return you will discover resources that match your personal development interests, a culture that welcomes your ideas and opportunities in a way that only a global leader can. Experience an opportunity to be working alongside enthusiastic colleagues who are dedicated to making a difference to the world. Come join us and make a difference too.




Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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