Kenny-Whelan (a specialist division of the CPL group) are hiring another QA Specialist to work on contract at Janssen in Ringaskiddy Cork.
Contact Jenn Dinan on 0214665408 or email jdinan@kenny-whelan.ie.
New vacancy Sept 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 + on it.
QA SPECIALIST - QA OPERATIONS
Position Summary:
This position is responsible for carrying out tasks and projects related to the management of Quality Assurance activities at Janssen Biologics as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review, and Validation compliance activities.
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality, and compliance goals are met.
GENERAL SCOPE OF RESPONSIBILITIES:
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality, and compliance goals are met following the J&J Standard of Leadership behavior model.
Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
Duties:
1. Batch Record Review & material release to ensure compliance with GMP requirements.
2. Administer event management systems including Review & Approval of Events, Deviations, and Customer complaints.
3. Manage batch records design and approval.
4. Administer the SAP Quality Management Module.
5. Manage site change control systems.
6. Compile Annual Product Reviews.
7. Support all validation activities on site as described in the Site Validation Master Plan.
8. Approve and compile validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
9. Support system qualification and process validation activities.
10. Review and approve SOPs/work instructions/forms from other departments on behalf of Quality Assurance.
11. Coordinate and assist in the preparation for regulatory and customer GMP inspections of the site.
12. Participate in the introduction of new or modified process steps as part of a New Product Introduction Team (NPI).
13. Perform GMP audits on-site and vendor facilities as required.
14. Conduct regular walkdowns to ensure process and facilities are maintained to GMP standards.
15. Administer the site supplier approval process.
Key Skills and Competencies required:
1. Excellent interpersonal skills.
2. Ability to operate as part of a team is critical.
3. Customer focus.
4. Innovative.
5. Excellent communication skills both written and verbal.
6. Attention to detail.
7. Good problem-solving skills.
8. Results and performance driven.
9. Adaptable and flexible.
10. Decision making.
QUALIFICATIONS AND EXPERIENCE:
ESSENTIAL - Quality Assurance Specialist - QA Operations:
1. Bachelors Degree in a scientific/technical discipline required.
2. A minimum of 3-5 years’ experience in a quality, validation, or compliance role within the biological and/or pharmaceutical industry.
3. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
4. Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA, and other authorities.
DESIRABLE:
1. Experience in auditing of external suppliers, contractors, and vendors.
All applications will be treated with the strictest of confidence.
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