Quality Assurance Specialist Senior 29061A
⦁ JobTitle: Quality Assurance Specialist Senior 29061A
⦁ About Company: Our client based in Dun Laoghaire is seeking a Quality Assurance Specialist Senior to join its expanding team
⦁ Duration of Role: 2 Years
⦁ Summary Objective:
The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility
⦁ Job Duties:
• Accountable for Quality oversight of processes and procedures related to IS, CS & Automation compliance
• Quality review and approval of Validation documentation and SOPs as they apply to IS, CS & Automation projects
o Review of DS & QRAES documents
o Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
o Review of executed validation documents and reports
• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
SKILLS AND REQUIREMENTS (no visa processing)
• University degree. Science or Engineering related discipline preferred.
• Relevant experience (5yrs +) working in the Medical Device, pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
• Understanding of Information Systems, principles of Automation and system architectures.
• Experience in cGMP regulated environments and knowledge regarding FDA cGxP and 21 CFR Part 11 regulations and an understanding software system validation is required and working knowledge of the GAMP software development lifecycle
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
Benefits of working with Independent Solutions
Benefit from Independent Solutions ethical principles!
We look after our team, we know the business, we have been working in the sector >20 years.
We are not a recruitment agency
While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross functional LifeScience team
We offer attractive rates – competitive margins compared to our competitors.
Payment on time and in full
We continue to partner and grow our client base and thereby ensure that we have continuous supply of High-Value Projects
We work for you !
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Tel: +353 1 5311 280
Fax: +353 1 5311 285