QA Specialist, Training & Systems (contract)
- Cork, Cork City
This role is required to support a team of 8 training and systems analysts, requiring project support on improvements to QA systems. You will be required to exercise judgment within well-defined and established procedures and practices to determine appropriate action, to identify problems and to generate alternatives and recommendations within defined processes.
Job duties include:
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Participates in developing and approving Standard Operating Procedures (SOPs).
- Review and approval of GMP Deviation investigations and CAPAs.
- Performs internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP.
- Performs QA site system support across a number of QA systems
- Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings.
Knowledge, Experience and Skills:
- 4+ years of relevant experience in a GMP environment-related field and a BSc.
- 2 + years of relevant experience and an M.Sc.
- Prior experience in the pharmaceutical industry is preferred.
- Working knowledge of cGMP's.
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Knowledge of FDA / EMEA standards and quality systems.
- Basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
- Experience with QA systems or Training.
- Good verbal, written, and interpersonal communication skills.
- Proficiency in Microsoft Office applications.
Full-Time/12 month contract
For a confidential discussion on this or any other current opportunity please contact Aisling Tighe on 021 233 9200 / [email protected]
Please note that your application to this vacancy will be forwarded to all the consultants in The Logiskills Group as you may be suitable for other roles that we are unable to advertise.
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