Are you a pharma/ biopharma QA aficionado looking for your next challenge?
Are you proficient in regulatory compliance with GMP?
SRG are supporting a business who provide key services to the biopharma industry by creating enzymes and other protein-based products. These products go on to support pharmaceutical, IVD and clinical chemistry around the world and have a huge impact across the industry.
This is a brilliant opportunity for a QA professional who is well versed in CAPA's, deviations, and change control, as well as being familiar working within GMP standards. If you looking to be a key part of a company who are under-going huge growth whilst maintaining a real family feel then keep reading.
You will be joining a company dedicated to future thinking, with a new GMP facility, constantly evolving services to clients. The business is also keen to reduce its impact on the environment, and does this by making its own water, and produces electricity on site, reducing its overall environmental impact.
- Review batch records prior to release of Diagnostic/Therapeutic Intermediate/Traded Products and IVDs.
- Assist in management of the internal audit and its program and conduct regular internal audits to assess compliance to appropriate FDA QSR 820, ISO 13485, and ISO 9001 requirements. You will also assist in external audits of supplier as directed.
- Prepare audit reports and raise non-compliance notices for areas which need improvement.
- Assist in management of the internal non-conformance management systems specifically CAPA, Deviations, Supplier Corrective Action Requests & close out of Customer Complaints.
- Assists in Customer Complaint Handling and Reporting.
- Perform training on quality issues as and when required.
To be successful in this role you will have:
- QA experience in a GMP environment including complain handling.
- Take initiative and able to establish strong relationships.
- Have extensive experience as a QA within pharmaceutical /biopharma industries.
- Be familiar working to ISO 13485, ISO 9001, QSR820, and GMP standards.
- Understand CAPA's, QMS, and deviations to a high level.
- Be familiar with complaint handling, and resolving within QA GMP regulations.
- A degree or relevant experience in Chemistry, Biology, or a related field.
Why work for this business?
- Brand new facilities and state of the art equipment
- Excellent benefits, including private medical, up to 10% matching pension and lots more.
- Relocation support for moving to Kent.
- Huge focus on corporate social responsibility including 5 paid days off per year for non-profit work and lots of environmental and CSR opportunities.
- Lots of long-serving staff members
To find out more about these fantastic opportunities or the other opportunities within R&D, or Analytical Transfer please get in touch with Amelia Rose at SRG.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.