Undertake annual reviews of products according to current legislation surrounding quality aspects, stability data and reports.
Compile and review all batch release documentation in preparation for QP review and release.
Carry out annual compliance audits, liaising with manufacturers and distribution, checking test reports.
Support the TD with the internal audit program, performing audits and compiling reports.
Assist with artwork process, check initial proofs and printing.
Check for all manufacturing deviations; document and investigate any occurrences.
Develop and maintain SOPs for the Quality Assurance department and ensure compliance.
Oversee all complaints regarding product quality; supporting investigations and providing feedback
Ensure product stability tests are carried out each year, checking they remain within specification, passing to the Technical Director should any issues arise.
Liaise with the Customer Services Co-ordinator regarding product releases, returns and assess stock based on SOPs.
Produce annual report of all product returns, complaints, deviations and defects.
Provide monthly quality KPI update to the Technical Director.
Create technical files for all company products.
Undertake ad-hoc projects as allocated by the Technical Director
In line with annual objectives, contribute and support the UK Affiliate in its pursuit to become more sustainable, ensuring that you and/or your teams commit to and deliver at least 2 initiatives each year.
favorable atmosphere for work and friendly staff;
professional and career growth, training and development;
full social package guaranteed by law;
voluntary medical insurance;
accident insurance, life insurance;
Pharmacist, valid Certificate of Specialist is preferred
5 years Quality Assurance experience/Warehouse Pharmacist Manager in the medical device/pharmaceutical is desired. Equivalent industry experience in similar field will be considered.
Upper-intermediate in English
Good writing and verbal communication skills
ability to work with minimal supervision;
analytical and investigational skills
Computer experience with Microsoft office.
Полная занятость, полный рабочий день, у работодателя