Up to €75,000
3 months ago
Hamlyn Williams have partnered with a global biotechnology company to assist them in hiring a Senior QA Validation Engineer to join their site in Ireland. The site has received over €325 million worth of investment in the last 2 years, hence there are plenty of new projects and opportunities for accelerated growth within the organization.
Main responsibilities will include:
- Leading a team of 4-5 engineers and using your expert validation and quality knowledge to guide and advise them.
- Lead the Validation Review Board; providing quality leadership for key functional areas including Supply Chain, QC, Engineering and CSV.
- Actively participate in the New Product Introduction and Tech Transfers.
- Review QA related activities in regards to facility, equipment and utility.
- Ensuring all approvals of qualification/validation documents conform to SOPs.
- Be the lead representative for internal and external audits.
- 10+ years’ experience working in a GMP environment.
- Previous experience leading a small validation team.
- Hands on experience with New Product Introduction and Tech Transfers.
- Wider validation knowledge including; method, shipping, cleaning, process and CSV.
- Strong understanding of change control, non-conformance and corrective and preventative measures.
- Greenfield experience is desirable not essential.
You can apply for this role by sending us your CV or by calling us now!
Contact: +44 203 545 1112 or email email@example.com.
You can learn more about me by looking me up on LinkedIn. Search for Ellen Hickey https://www.linkedin.com/in/ellen-hickey-609a33b7/.