Walker Cole International is supporting a leading pharmaceutical manufacturer in the appointment of a Quality Consultant to provide Quality Assurance support across qualification and validation activities within a GMP-regulated manufacturing environment.
This position will focus on the review and approval of qualification and validation documentation relating to equipment, software and manufacturing processes, ensuring compliance with GMP requirements, site procedures and regulatory expectations. The successful candidate will work closely with the Quality team to support critical site compliance activities and project deliverables.
Key responsibilities:
- Provide Quality Assurance support for qualification and validation activities across equipment, software and manufacturing processes.
- Review and approve qualification and validation documentation, ensuring compliance with GMP requirements and internal quality standards.
- Support qualification activities through review of IQ, OQ and PQ protocols, reports and associated quality records.
- Perform documentation reviews from a quality and compliance perspective, identifying gaps and ensuring documentation is inspection-ready.
- Collaborate with Validation, Engineering, Manufacturing and Quality teams to ensure qualification deliverables are completed on time and to the required quality standards.
- Identify, assess and escalate quality or compliance risks associated with qualification and validation activities.
- Provide QA oversight and guidance throughout qualification and validation projects.
- Ensure all documentation aligns with site quality systems, regulatory requirements and internal procedures.
- Support resolution of quality-related issues arising during qualification activities.
- Contribute to maintaining a compliant and audit-ready validation and qualification programme.
Required experience and skills:
- Proven Quality Assurance experience within GMP-regulated pharmaceutical, biotechnology or life sciences environments.
- Strong experience reviewing and approving qualification and validation documentation.
- Working knowledge of equipment, process and software qualification activities.
- Experience reviewing IQ, OQ and PQ protocols, reports and associated validation records.
- Strong understanding of GMP requirements, quality management systems and regulatory expectations.
- Ability to identify compliance risks and provide practical quality guidance to project teams.
- Experience working closely with Validation, Engineering and Manufacturing functions.
- Excellent document review, attention to detail and problem-solving skills.
- Strong communication and stakeholder management capabilities within cross-functional environments.
- Ability to work independently and manage multiple priorities in a fast-paced project environment.
Working pattern:
5 days onsite, full-time hours
Employment type:
3-Month Contract (Initial Assignment)
Location:
Southwest England, United Kingdom
Start date:
June (ASAP)
Keywords:
Quality Consultant | QA Consultant | Quality Assurance | GMP | Validation | Qualification | IQ | OQ | PQ | Equipment Qualification | Software Validation | Process Validation | Compliance | Quality Systems | Documentation Review | Pharmaceutical | Biotechnology | Life Sciences | GMP Compliance | Audit Readiness
ID: 107623