PE Global is currently recruiting for a QA Specialist on behalf of our client based in Cork.
Position Title: Quality Systems Specialist
The QS Specialist main responsibilities will be:
- Supporting the digitalization and automating of quality systems to drive data insights, technology, and process innovation
- Reimagine innovation through integrated quality systems
- Drive internal/external partner support to deliver e2e customer value, by supporting the implementation of the next generation Quality Systems.
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 also 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 nonconformance 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
GENERAL SCOPE OF RESPONSIBILITIES:
Reporting to the QS Team Lead, 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:
o Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
o Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
o Keeps abreast of regulatory compliance trends.
QUALIFICATIONS AND EXPERIENCE:
- The position of QS Specialist requires a third-level qualification (scientific/ engineering/ IT/ BIS discipline required)
- Experience with one or more data analytics techniques and tools such as Tableau, Spotfire, Google Analytics, Rapid Minor, or Python, and intermediate/advanced Excel will be a distinct advantage.
- 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 also 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 behavior
- Attention to detail and strong administrative skills
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on or alternatively send an up-to-date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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