Job Reference: JO-2208-66287_1667304251
I am working with a pharmaceutical organisation based in Cork that has an excellent 12 MONTH contract opportunity for a Quality Specialist to join their busy site. If you have experience in quality validation and qualification within a GMP environment please reach out for a confidential conversation!
- 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.
- 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
- Minimum qualification of a Bachelor's 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
- Skilled in the execution of Risk Assessment and in the use of a variety of problem-solving techniques
- Experience in projects, audits & inspections as QA SME
- Experience in the current Quality and regulatory standards by FDA. EudraLex etc.
- 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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