Purpose and Scope
The Quality Assurance Specialist will ensure the effective administration, monitoring and completion of the Pharmaceutical Quality System including review and approval of Site Polices, SOPs, Work Instructions, logs and forms and ensuring compliance to those procedures.
Key Responsibilities and Accountabilities
To provide Technical Quality support to the Analytical Services for new and ongoing projects including review and approval of:
- Analytical Method Development/ Verification Protocols and Reports
- Client Supplied Methods and Specifications
- Test Data, Calculations, results and Certificate of Analysis
- Equipment Maintenance and Qualification
- Temperature Data
- Approved Supplier list
- Support investigations, review and approve Deviations, Out of Specifications results and Requests for Change, giving consideration to GMP conformance and compliance to Regulatory guidelines.
- To conduct self -inspection audits and maintain site metrics to present a Quality Management Review.
- Assist in external inspections, supporting QA Director.
- To review non-compliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate quality decisions, and to initiate and promote quality improvements to prevent re-occurrence.
Personal
- Team player, able to manage different stakeholders and policy processes
- Flexible, able to juggle demands and manage competing priorities
- Self-motivated, the job holder is required to work on their own initiative and largely independently on key responsibilities under the supervision of the Quality Director.
- The nature of the role requires consistency of attitude and behaviour from the job holder to all aspects of Pharmaceutical Quality Assurance and the constant pursuit of excellence and efficiency throughout the organisation.
- The role demands technical knowledge, high standards of attention to detail and the desire to see tasks through to completion.
- A strong problem solving ability is needed to assist team members in identifying and eliminating problems. Where qualified, the job holder will also be required to train other personnel in quality system procedures and approaches.
- The job holder must command the respect of peers and co-workers and constantly uphold the company values in every aspect of their role.
- A high degree of influencing skills will also be required in order to gain the delivery support required from personnel over whom the job holder may have no direct authority.
Safety:
- The job holder is responsible for adhering to CatSci Ltd SOPs, Health & Safety, GMP and other regulatory guidelines, to report near misses and improve CatSci safety culture
Knowledge and Skills
- Educated to degree level (or relevant industry experience in Pharmaceutical Science).
- Experience in regulatory audits
- Experience in working in a regulated environment and being able to manage projects.
- Evidence of continued professional development