What you need to know
You will work as a Senior Quality Officer for our client within their expanding pharma manufacturing facility in Waterford City.
You will manage and co-ordinate Quality Assurance activities and resources associated with the Pharmaceutical manufacturing and release of Products.
This is a 2-year fixed contract
Your new job
Key duties & responsibilities:
- Responsible for facility compliance with regulatory commitments, in-house requirements and cGMPs.
- Introduction of quality systems.
- Responsibility for maintenance and development of GMP awareness facility-wide, including: preparation and execution of training programmes, procedures and policies, assessment of GMP training requirements, and execution of internal GMP auditing.
- Exception and deviation management e.g. deviations, Alarms, OOS, etc.
- Regulatory- Maintenance of site master file, preparation of annual reports/activities, trending of complaints etc
- Validation- Provision of support and assistance in execution and control of validation programmes.
- Participate in team-based project work and plant-wide initiatives to improve the GMP compliance and financial performance.
What are we looking for?
- At least 5 years’ experience in a GMP regulated environment.
- Experience of scientific report writing including such documents as SOP’s, protocols, deviations, reports etc.
- Ability to evaluate and assess information to determine appropriate risk and required actions is critical.
Apply for this job now by sending your CV to Patricia.
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