QC Senior Technologist (Analytical)
QC Senior Technologist (Analytical)
Permanent Position
Porton Biopharma Ltd, Porton Down
37.5 hours per week
£26,984.00 to £34,154.00 depending on experience
Our client has approximately 200 staff, performing a range of process and analytical development, production, quality control and quality assurance roles associated with the development and manufacture of biopharmaceuticals.
The department carries out the manufacture of Erwinase and Anthrax Vaccine, as well as contract manufacturing projects and due expansion they are seeking a QC Senior Technologist (Analytical) .
Analytical Quality Control Laboratory
The Analytical Quality Control Laboratory is part of the Development and Manufacturing Group at Porton Down which develops and manufactures biopharmaceutical products according to cGMP requirements. The laboratory is responsible for provision of analytical chemistry services to support quality control testing of products, raw materials and water systems. A stability study programme is also maintained to meet regulatory requirements for marketed products.
Role information:
To undertake chemical and biochemical analyses to support the manufacture of Porton Biopharma’s licensed pharmaceutical products; as required by EU Directive 91/356/EEC for GMP compliance. To supervise and schedule work for QC Technologists. To write quality documentation relating to raw materials, water and product testing. To ensure that work performed within the laboratories is carried out in compliance with corporate statutory health and safety requirements,
Duties and Responsibilities:
- To deputise for the QC Analytical Unit Manager when required.
- To supervise Junior QC Analytical staff.
- To schedule work for QC Analytical staff members to ensure that manufacturing deadlines are met.
- To ensure analysis and recording of QC and stability testing has been performed in compliance with the statutory requirements of cGMP.
- Responsibility for testing raw materials, in process and finished product samples to ensure that they meet the specifications established in the product licence and internal Porton Biopharma specification documents.
- Responsible for writing Standard Operating Procedures and their associated risk assessments to ensure that those tasks are performed safely.
- Organise and liaise with external testing laboratories to arrange correct and on time testing to meet production deadlines.
- Maintain an up-to-date awareness of regulatory and scientific developments via courses, meetings and literature.
- Responsible for the verification of analytical raw data and release of results from the QC Analytical department.
- Responsible for writing quality records such as non-conformances, CAPAs and change controls.
- Undertake work in accordance with Porton Biopharma’s Code of Safety Practice and Quality Systems
The successful candidate will have/be:
- Strong history of working within a GMP QC environment preferably but not restricted to Biopharma, small molecule will be acceptable. The department has more of a biochemistry direction rather than chemistry.
- Strong GMP skills
- Excellent written and spoken English.
- Good documentation skills.
- Good organisation and prioritising skills
- Good understanding of a variety of suitable analytical techniques.
- The successful candidates will be primarily responsible for technical review of data, writing SOPs, non-conformances, OOS investigations, change controls; therefore previous experience in some of these is essential. They will also be expected to perform analysis and train/guide analysts.
- Degree in Chemistry/Biochemistry or other suitable degree.
Suitable experience may be considered as suitable
