- 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.
- 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
- 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 Competencies Required:
- Collaboration and teamwork
- 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
- Builds strong productive relationships
- Seeks opportunities to grow and develop professionally
- Uses best practices to improve business operations
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email email@example.com