Sector: Life Sciences
Consultant: Matthew Pitcher
Salary: £40000 - £60000
Job Status: Permanent / Full Time
We are excited to be working with this fantastic client, looking for a International QA Auditor, this role is based in Scotland and would be perm office based position.
- To Carry out GXP audits for CMO, Suppliers, Service providers etc
- Key Responsibilities: (what are the tasks, duties and responsibilities?)
- To prepare annual audit plan.
- To carry out GXP audits of suppliers, CMOs and Service providers
- To carry out self-inspection of affiliates and our departments.
- To support for hosting GXP audits.
- To review and approve stability, validation, tech transfer and technical protocols.
- To carry out GXP trainings.
- A Life Science degree or equivalent
- A broad experience of working within the Pharmaceutical industry of which several years should have been in QA GMP auditing.
- Excellent working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials
- Sound knowledge of the principles of solid and semi-solid dosage manufacturing processes (tablets, capsules, gels, creams, ointments)
- Sound knowledge of QC and Stability chemical analytical testing techniques for solids and semi solids
- Familiar with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, computerised systems
- Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines
- Familiar with Quality Management Systems e.g. ICH Q10
- Regular Worldwide travel (50-70%)
- Good interpersonal and communication skills
- Sound technical knowledge of Pharmaceuticals
- Good analytical and problem solving skills
- Good writing and presentation skills
- Team working and team development
- Working experience of Quality Systems
- Ability to operate in a “virtual” pharmaceutical environment
- Maintain a high visibility and credibility with management and staff