Our client, a pharmaceutical company is currently looking to recruit a Quality Systems Specialist for their site in Cork on a 12 month contract basis.
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
- Supporting site regulatory inspections where appropriate
- Supporting the site induction process
- Metrics and report generation from the quality systems
General Scope of Responsibilities:
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.
Key Competencies Required:
- Collaboration and team work
- Strategic thinker
- Problem solving and attention to detail
- Results and performance driven
- Coaching and mentoring style
- Integrity, trustworthiness and objectivity
- Customer focus
- Clear communication skills
- Adaptable and flexible
- Inclusive, facilitative style
Qualifications and Experience:
- 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
Key Individual Contributor Competencies:
- 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 role in Cork please contact Nick Harrison on 086 0468858 / firstname.lastname@example.org
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