A new role has become available for a GMP QA Expert to join the Quality team of an exciting clinical stage Biotech in London. Are you an experienced and ambitious with experience in pharmaceutical Quality Assurance and interested in the opportunity to manage Analytical Chemistry Projects to support clinical manufacturing?
- Work in collaboration with international and domestic teams to provide Quality Assurance oversight to the production and testing of small molecule drugs for clinical trials.
- Reviews and approves batch production records, stability protocols and reports, and other documentation to support small molecule production and testing.
- Oversee and manage deviations, change controls, and CAPAs at our vendors as well as within the Quality System.
- Perform audits of vendors, as needed.
- Provide support to QA Validation to oversee validation efforts at vendors.
- Communicate effectively with internal and external teams to drive projects through to completion
- Work effectively with the CMC team to drive alliances and network with collaborators and consultants.
- Interact with the FDA and other Regulatory Agencies in support of inspections and information requests.
- At least a Bachelor’s degree in chemistry
- Last 6+ year’s industrial experience in a QA environment.
- Experience with production and analytical methods using a range of chromatographic techniques including HPLC, GC and LC-MS
- Ability to work independently and make quality/compliance based decisions
- Excellent project and data management skills and a keen attention to details
- Excellent communication skills for both written and verbal presentations
- Evidence of strong strategic thinking, planning and organizational skills
- Experience in GMP manufacturing
- A knowledge of the regulatory requirements associated with small molecule production and analytical methods.