- Supports the compliance plan and quality metrics generation
- Complete review and approval of documentation
- Leads walk down and support audits
- Participate in the preparation for and hosting of regulatory and customer audits
- GMP training delivery to personnel
- Investigation of Minor Deviations
- Provide Compliance guidance to Operating procedure
- Review Deviation trends and identify effective CAPA's where necessary
- Member of the site PIR team works with team to ensure that the department is inspection Ready.
- Proactive monitoring of CAPAs to ensure holistic trends are proactively resolved
- Participates in the overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA
- Participates in Quality Risk Management.
- 4 years' experience in pharmaceutical industry.
- >2 years' experience in operation /Quality role.
- Demonstrated technical knowledge and experience in compliance (GMP, Eng, Technical.
- Degree in (Science/Engineering)
- Communication skills both written and oral including persuading others
- Technical report writing
- Time management
- Problem solving skills applied to issue identification and resolution
- Responds to non-standard requests
- Supports cross functional investigations
- Timely decision making.
- Demonstrated initiative and pays attention to detail
- Good presentation skills. Advanced PC skills such as Excel, Word, PowerPoint.
- Demonstrate the ability to coach and influence others
- Organization Skills: Ability to manage multiple priorities and to know when to escalate issues for resolution
- Proven ability to work as part of a highly motivated team member
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists