Senior Quality Associate

OVERVIEW

Established in 2001, CST Pharma are the UK’s number one specialist in the parallel import and parallel export of branded pharmaceuticals, generic medicines, medical appliances, diagnostics and unlicensed medicines.

We have developed long lasting close relationships with suppliers and customers across the globe. We specialize in supply to wholesalers, Pharmacy groups, hospitals, Private hospitals, specialist clinics, clinical trial providers, charities, NGO’s and many other healthcare providers. Generation a group turnover in excess of £150 million per year.

In 2012 we launched our sister company Acre Pharma with the objective of establishing our business as a respected and reliable supply partner to pharmaceutical businesses outside of the EU. Now well established on 5 continents.

Job Responsibilities: Senior Quality Associate

• QA support to all other departments within the company.
• Assist in the maintenance and management of the company's QMS.
• Bulk and packed/labelled material and co-ordination and control of certification/release process together with QPs.
• Writing/review/approval of internal Quality documents/records (deviations, CAPAs, Change control, SOPs, complaints).
• Conducting Self-Inspections/internal and site audits.
• Conducting supplier/vendor approval via different assessment methods including site audits.
• Support QA team in maintain and managing the company's Quality and Technical agreements including writing, review and approval.
• Support QA team in monitoring and management of all QA aspects of contract labeling GMP and GDP activities .
• QA review and approval of external documentation and records (deviations, Change Controls, specifications, master batch records QC methods, validation protocols and reports.
• QA support for licensees.
• Prepare the company for any GMP/GDP inspection or Due Diligence by regulatory authorities and Licensees.
• Supporting/hosting GDP/GMP inspection or Due Diligence by regulatory authorities

Skills and Requirements:

• 0 - 5 years working within Quality in the Pharmaceutical Industry.
• Supplier/vendor approval, including site auditing.
• Practical use of EUDRA/FDA/ICH guidelines and regulations.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.