Kenny-Whelan (a specialist division of the CPL group) are hiring another Quality Systems Specialist to work on contract at Janssen in Little Island Cork.
HYBRID Role - 3 days onsite
Contact Jenn Dinan on 0214665408 or email jdinan@kenny-whelan.ie
New vacancy Oct 2024
Eligibility: Must already be eligible to work on contract in the Republic of Ireland, i.e., have a valid work permit with 12 months permission.
Quality Systems Specialist
Department: Quality Systems (QS)
Report to: QS Manager
Location: Cork
Travel: N/A
POSITION SUMMARY:
The QS Specialist's main responsibilities will be:
1. Supporting the digitalization and automation of quality systems to drive data insights, technology, and process innovation.
2. Reinventing innovation through integrated quality systems.
3. Driving internal/external partner support to deliver end-to-end 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 facilities. The candidate must also build customer value through effective collaboration and influencing others, as well as consistently delivering on goals and objectives under minimal direction.
Responsibilities include:
1. Internal Audit Program.
2. Management of the document management system, including supporting and advising Documentation Control administration personnel as required.
3. GMP service providers program.
4. Managing the nonconformance system and CAPA process; Quality agreement process; Change control process and system.
5. Supporting site regulatory inspections where appropriate.
6. Supporting the site induction process.
7. 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:
1. Providing support, direction, and training to all departments regarding specific quality system elements to ensure business, quality, and compliance goals are met.
2. Partnering with other departments to ensure compliance systems are implemented efficiently.
3. Supporting the development and management of GMP compliance systems through various activities.
4. Assessing compliance systems on an ongoing basis to identify opportunities for process improvement.
5. Staying ahead of regulatory compliance trends.
Key competencies required:
* An analytical and critical problem solver.
* Collaborative and a teammate.
* Strategic problem solver.
* Attention to detail and results-driven.
* Integrity, transparency, and objectivity.
* Customer-focused.
* Strong social skills.
* Adaptable and flexible.
* Innovative.
* Inclusive, facilitative style.
QUALIFICATIONS AND EXPERIENCE:
ESSENTIAL:
* The position of QS Specialist requires a third-level qualification (scientific/engineering/IT/BIS field required).
* Experience with one or more data analytics techniques and tools such as Tableau, Spotfire, Google Analytics, or PowerBI, 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.
DESIRABLE:
* Experience of running 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.
* Seeks opportunities to grow and develop professionally.
* Uses best practices to improve business operations.
* Effectively manages and adapts to change.
* Maintains the highest standards of ethical behaviour.
All applications will be treated with the strictest of confidence.
Contact Jenn Dinan on 0214665408.
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