- Ensure that quality standards are implemented on the project
- Ensure compliance with quality and industry regulatory requirement
- Provide professional and timely inputs/directions and ensure the right level of quality in projects.
- Prepare data/reports to communicate outcomes of quality activities.
- Attend meetings (e.g. board/project/portfolio/department meetings).
- Identify training needs and organize training interventions to meet quality standards.
- Ensure update of Quality documentation: write Procedures and directions for recording and reporting quality data in projects, for documentation owned by Quality departments.
- Ensure the link between Project Manager and Regulatory Responsible on site.
- Reviewer/Approver of Change Controls.
- Reviewer/Approver of Qualification/Validation Documents (e.g. validations (master) plans/reports, (User) Requirement Specifications, DQ, IQ, OQ, PQ, PPQ/PV, RCL, RTM, risk assessments, SOPs).
- QA oversight of qualification and validation activities on the project
- Participating in continuing professional development in order to maintain awareness in current and new regulations and ensuring new regulations are implemented.
- Execution of Risk Assessment and in the use of a variety of problem-solving techniques
- Minimum qualification of a Bachelor Degree in a scientific/technical discipline required
- 5 years' experience working with quality and cGMP in the pharma industry.
- Experience in C&Q and life cycle qualification/validation support.
- Experience working across a Global business a distinct advantage, projects, audits & inspections as QA SME
- Experience in the current Quality and regulatory standards by FDA. EudraLex etc.
- LEAN and Six Sigma philosophy are embedded in your day to day working
- A good communicator and when collaborating
- Work independently with strong personal drive
- Strong attention to detail and organisational skills
- Have the ability to critically assess issues and devise and execute appropriate solutions using problem solving techniques in a decisive manner
- Travel may be required as part of the role to represent Global Quality on elements of project implementation
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists