QA Officer

Recruiter
THERMOFISHER
Location
Lower Gornal
Posted
19 May 2019
Closes
21 May 2019
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job ID : 69677BRLocation : United Kingdom - Swindon : Job DescriptionWhen you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.At our site in Swindon, ThermoFisher are forging partnerships that are transforming the industry, creating new business models between pharma companies and their pharma service providers. We are pioneering solutions that are driven by client needs, with successful recent partnerships including Flexion and Pacira.We currently offer solutions spanning the entire pharmaceutical life cycle to help pharma and biotech companies of all sizes meet their complex development and manufacturing needs at any stage or scale enabling us to deliver a combination of unrivaled quality, reliability and compliance, backed by a reputation for scientific and technical excellence.The range of services at ThermoFisher for drug substances and drug products is wider than that of any other CDMO and we offer end-to-end capabilities and expertise to take your discovery from pre-clinical and clinical development, through scale-up, all the way to commercial supply across more than 40 oral solid, sterile and softgel dosage forms.How will you make an impact?Reporting to the QA Team Lead the successful applicant will join one of our Condo Clients working closely with Production and Engineering to ensure new products are manufactured in accordance with cGMPActing as first line of contact for operational quality advice and support for your Condo you will play a key role in driving early detection to help prevent potential quality issues. Key Accountabilities As a QA Officer you will be part of a multi-functional Condo responsible for implementing quality systems and related processes from project phase (equipment and process validation) to full cGMP commercialization for one of our clients.This is a diverse and challenging role with key accountabilities including:Providing Quality Input on the life cycle of Validation documents from URS’s through to PQ’sImplementing QA on the shop floor; reviewing sterilization cycles, FMS systems and cleanroom logbooksProviding quality and compliance input in reviewing of Batch Manufacturing Record Reviews, CAPA’s & Deviations, Complaints & OOS across departments.Review and update of Standard Operating Procedures and Controlled Documents as required.Working closely with the site Qualified Persons (QPs) ensuring batch release schedules are adhered to.Closure of batch records with associate LIMS & SAP transactions & C of A generation.Local area & local system audits.Media fill observation, reading & report writingProviding annual product reviews for our client’s product.Participation in investigating customer complaints.Cleanroom opening support (requalification of equipment & services).ExperienceYou will be a flexible, highly motivated and experience Quality professional seeking a new opportunity to develop and grow your skills within a unique operating model. To be considered for this role you will have experience of the Pharmaceutical industry and a strong understanding of current GMP and technical processes. In addition to this we are looking for an individual who is able to demonstrate Minimum Science based degree.Proven industry experience in a Quality Assurance Pharmaceutical manufacturing environment.A working knowledge and practical experience with 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.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.

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