Quality Specialist – Ceredigion, Up to £37,300 + bonuses , private healthcare etc.
WHO ARE THEY…
Our Global Pharmaceutical client, who has a manufacturing site near Llandysul is seeking a Quality Specialist on a permanent basis!
THE POSITION…
- Responsible for maintaining the standard of the quality system documents generated by the Quality Control team.
- Key individual for high risk quality events and change controls, ensuring quality records and SOPs are accurate and actions closed within the allotted timeframe.
- Provide technical input into validation activities and assay development and for the Quality Control team – write, review, approve and execute studies as required.
- Lead technical representative at site cost improvement initiatives (VIPs and CoGs).
- Work alongside Manufacturing Technical Support to transfer new equipment and techniques to laboratory scale.
- To foster and encourage Continuous Improvement within the Quality Control department. Lead process improvement initiatives and activities to influence change.
- To actively maintain and update knowledge and expertise of current developments, standards and operating practices within the biotechnology and pharmaceutical industries
- Input into the Regulatory strategy and author the relevant sections of Regulatory dossiers.
ABOUT YOU…
- Ideally Educated to degree level in an appropriate scientific discipline or in-depth experience of the industry.
- Significant experience in a biopharmaceutical or closely related industry.
- Excellent understanding of cGMP legislation
- Computer literate.
#sunnyjobs
IND123