QC Analyst - Senior 36766J
JobTitle: QC Analyst – Senior 36766J
About Company: Our client based in Cork is seeking a QC Analyst – Senior to join its expanding team
Duration of Role 12 months
Summary Objective Ensuring that activities are carried out in compliance with cGMP and company quality standards. Understanding and supporting current regulatory trends and future testing requirements and participating in relevant internal and external QC related audits.
• Generating site trends (utilities) and annual reports whilst supporting the identification of appropriate corrective and preventative actions.
• Supporting the delivery of aseptic technique training to site.
• Act a QC micro liaison with Operations, supporting Plant Microbiologist with process related investigations.
• Provide technical troubleshooting support during site failure and lab investigations.
• Provide QC representation on the Critical Utilities Team.
• Provide internal & external technical troubleshooting of QC Microbiology testing methodologies and techniques.
• Collating and reviewing of QC related data used to support regulatory filings in addition to addressing any requests for information from health authorities.
• Ensuring that our microbiological testing strategy is consistent with GMP requirements (Annex 1 & Annex 2 EU GMP) and company requirements as per Platform.
• Support the deployment of rapid micro techniques & new emerging technologies that may be applied in QC.
• Provide internal & external support during audits to QC and OPS.
• Ensuring that the design and qualification of QC testing is performed according to GMP requirements.
skills and experience
• An MSc or BSc in Microbiology or related Scientific discipline.
• 5+ years’ experience within a regulated biologics or pharma industry with a preference for candidates with prior Process &/or QC Microbiology experience.
Benefits of working with Independent Solutions
> Excellent Team of Colleagues
> Access to high-value projects
> Excellent Technical Project Managers
> Excellent pay & conditions
Independent Solutions are Approved Suppliers for Multinational Pharma Biotech, Medical Device, clients with locations based here in Ireland.
At Independent Solutions, we will not require you to become an employee of Independent Solutions, we will facilitate and support you to become an independent contractor, thereby reaping the maximum rewards from your contract role.
We work in the area, we know the business, we are not a recruitment agency!
We continue to partner and grow our client base and thereby ensure that we have continuous supply of excellent roles
Yes, of course we benefit from having YOU with US, but we can assure YOU that YOU too will benefit …
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Tel: +353 1 5311 280
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