When 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.
As primary point of contact, you will be accountable for providing QA oversight of Validation and Requalification activities, for both existing and new areas at our site in swindon.
You will ensure cGMP, SOPs and industry standards are applied within the area of work you will enable compliance with cGMP in all areas of the business as required.
This is a diverse and challenging role with key accountabilities including:
- Providing quality and compliance input to Validation and Requalification documentation.
- Undertake QA review and approval of Validation and Requalification documentation; examples include but not limited to:
- Routine requalification protocols (VALPROs)
- Validation “V”-model documents (VMP/ VP, URS, VDS. ERES, SQDQ, IQ. OQ, IOQ, PQ, FSR, VMPR/VPR) for equipment, facilities, utilities and systems
- Process and cleaning validation protocols and reports
- Media fill protocol and reports
- Requalification, cleaning and process validation protocol deviations and CAPAs
- Requalification schedule approval
- Internal audit and inspection observations, responses and CAPAs
- Proactive instigation, generation and timely investigation/review/approval of deviations, CAPAs and Change Controls in conjunction with validation/requalification staff and/or other departments
- Review and approve SOPs and other Controlled Documents as required
- Prepare, review and approve technical documentation within the department/site, as required.
- Carry out and support new product introduction within the department and cross-functionally across site
- Be up to date with Regulatory updates, Industry best practice, and Corporate standards/guidance (within area of responsibility), aligning local SOPs, systems and practices accordingly
- Undertake and support audits
- Undertake self-inspections
- Training / coaching of Validation / requalification staff, developing a strong quality awareness and culture
- Ensure own KPIs, plans, targets and objectives are effectively monitored and achieved
- Deputises for other QAO’s in the department
You 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 validation processes.
In addition to this we are looking for an individual who is able to demonstrate
- Degree in Pharmacy, Chemistry, Biology, or strongly related scientific discipline
- Experience in a pharmaceutical QA or Validation function, preferably within a sterile manufacturing site
- Demonstrates a good knowledge of Validation and Pharmaceutical Technology principles
- Ability to work to critical timelines and in an environment with changing priorities
- High attention to detail, data and fact driven, with the ability to easily assimilate and evaluate technical and scientific data
- Pragmatic, with the ability to assess an issue holistically
- Strong quality and compliance focus and ethics
- Has the drive and maturity to lead, combined with the ability to support and interface effectively with projects and motivate cross-functional teams.
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.