Do you have strong QA experience in GMP and GDP and the passion to join an innovative Pharmaceutical business? A brand new role has been created for a QA Officer / Associate, to work mostly from home somewhere in the Midlands, North West England or Wales.
This is an excellent opportunity to join an innovative pharmaceutical company at a key time in its development to support the launch of its first licensed product. The company is developing a number of exciting new products with the most advanced just being granted marketing authorisation. To support the manufacturing and distribution, a new QA Officer position has been created to bring the full range of GMP and GDP expertise into the company. This will be a broad role at QA function ownership and hands-on levels while acting as the company’s GMP QA SME. All manufacturing and distribution activities will be outsourced to third-party service providers, hence the role can be predominantly home-based. The company is offering a very competitive salary which can be discussed on application.
The Company
The company is a specialty pharmaceutical organisation that benefits from substantial backing and is listed on the AIM stock market. It operates as a “virtual company” with a core of integrated professionals backed by a strong, entrepreneurial management team. Having gained marketing authorisation for an initial product the company is now planning for the manufacturing, distribution and marketing later this year. It also boasts a strong pipeline of further products in pre-clinical and clinical development to back its goals of long term sustainability through innovation.
The Role
This is a brand new, key strategic position to bring GMP and GDP expertise into the company. The role will be responsible for the quality and compliance of the Quality Management System (QMS) and development/commercial activities related to GMP/GDP. The GMP/GDP QA Officer will report to the Head of Quality and support the Responsible Person/Supply Chain Manager in all aspects of the QMS. Specific responsibilities will include:
- Review and approval of development and commercial GMP/GDP documentation
- Review and approval of Quality Technical Agreements with CMOs
- Review and assessment of supplier quality metrics
- Oversight of GMP/GDP SOPs
- Ensuring harmonisation across GxPs in relation to continued development and innovation
- Ensuring the business is driven by continual improvement in quality through robust CAPA processing and change control.
- Planning, preparing and conducting GMP/GDP audits of suppliers while maintaining constant audit readiness to successfully host regulatory agency inspections.
- This role will cover products going into commercialisation as well as drugs in clinical trials.
A full and detailed job description is available on application.
Experience
We are seeking an experienced GMP/GDP professional capable of establishing themselves in this position while driving the standards for this new function and acting as the company SME. You will ideally have 5+ years’ relevant QA experience and be capable of working at QA ownership and hands-on levels. Your expertise will cover all aspects of GMP/GDP documentation, QMS ownership, SOP management, CAPA tracking, process improvement, auditing and training/mentoring. In addition you should be used to working with, and having oversight of, external suppliers including CMOs.
Full details, including salary and job description, will be provided on application.