Job Description

The ideal candidate will have a degree in a scientific subject. Substantial previous experience in a pharmaceutical GMP environment in a Quality Assurance role is an essential requirement.

PRIMARY OBJECTIVES

Support the Quality Manager to ensure compliant and efficient operation of the Quality Management System and deputies for the Quality Manager in their absence.

Act as a subject matter expert within the following areas of functional expertise to ensure compliant and efficient operation of the following systems / processes:

Quality Management System:

Document Management

Internal Audit process and program

Management Review – preparation of data / metrics

Quality process monitoring – oversight and maintenance of tracking systems for all quality-critical processes

Customer technical agreements

Data integrity – oversight and maintenance of site Data Integrity

Horizon Scanning

Site validation, calibration and equipment maintenance:

Equipment qualification and associated process validation

Cleaning validation & cross-contamination risk assessments

External audit management:

Customer / third-party audits

Regulatory inspections

Supplier Management:

Supplier selection, qualification and auditing

Supplier performance reviews

Act as a lead auditor for internal and external audits.

Work remotely:

• No

Required Knowledge, Skills, and Abilities

· Excellent attention to detail, · Analytical and problem-solving abilities, · Detailed knowledge of root cause analysis and risk management tools and their application, · Good understanding of applicable regulations, standards and best practices, · Good communication, interpersonal and influencing skills, · Good numerical skills and the ability to handle and analyze data, · Sound knowledge of data analysis tools (e.g. Excel, Minitab etc.), · The ability to present complex information (both internally and externally) to diverse audiences and levels of understanding, · Planning and project management skills.