Our client is a pharmaceutical company based in Cork looking for A Quality Systems specialist
Department: Quality Systems
Report to: QS Manager
- The candidate must have a broad knowledge of cGMPs and prior experience of working in HPRA/FDA regulated facility. The candidate must also build customer value through effective collaboration and influencing others, as well as consistently delivering on goals and objectives under minimal supervision.
- The individual will be responsible for (some of the following):
- Internal Audit Program
- Management of the document management system- which can include supporting and advising Documentation Control administration personnel, as required
- GMP service providers program
- Managing the non-conformance system and CAPA process
- Quality agreement process
- Change control process and system
- Supporting site regulatory inspections where appropriate
- Supporting the site induction process
- Metrics and report generation from the quality systems
- Reporting to the QS Manager, the person will be responsible for the following:
- Providing support, direction and training to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
- Partners with other departments to ensure that compliance systems are implemented in an efficient manner.
- Supports the development and management of GMP compliance systems through the following activities:
- Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
- Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
- Keeps abreast of regulatory compliance trends.
The Ideal Candidate:
- The position of QS Specialist requires a third-level qualification (scientific/ engineering/ IT/ BIS discipline required)
- A minimum of 3-5 years’ experience within the biological and/or pharmaceutical/ medical device industry
- Knowledgeable of FDA/EMEA regulatory requirements
- Demonstrated knowledge and application of industry regulations as they apply to systems including those of FDA, HPRA, EMEA and other authorities
- Experience of managing project groups or leading teams
- Skilled in the use of problem solving tools/techniques
Experience with systems such as Trackwise and electronic documentation management systems will be a distinct advantage
- Customer focus is critical
- Builds strong productive relationships
- Demonstrates ability to work with teams and individuals
- Asserts personal ideas and opinions using persuasion to influence others
- Seeks opportunities to grow and develop professionally
- Uses best practices to improve business operations
- Holds oneself accountable for compliant and flawless execution
- Effectively manages and adapts to change
- Demonstrates the courage to stand alone on ideas and opinions that differ from others
- Listens effectively and remains open to other’s ideas.
- Works effectively with people that have diverse styles, talents and ideas
- Maintains the highest standards of ethical behaviour
- Attention to detail and strong administrative skills
For further information on this Quality Systems Specialist in Cork please contact Orla on 086 0449473 / email@example.com
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