KENNY-WHELAN (a specialist division of the CPL group) are recruiting 3x MORE QA SPECIALISTS to work on contract at JANSSEN SCIENCES in Ringaskiddy Cork.
Contact JENN DINAN via the link below or email directly to jdinan@kenny-whelan.ie.
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 - HYBRID Role - 3 days onsite
One role is for the QA Team that supports AD labs which are the Centre of Excellence for biologics, Clinical Release and Stability (Phase I-III).
Responsibilities:
1. Quality oversight Non-Conformance/CAPA investigations in AD.
2. Attend and give clear compliance input at Risk Assessments, RCPS and A3 meetings.
3. Perform the assessment and closure of change controls on time.
4. Support any new technologies for implementation with the BioTD AD, QC and lab services groups.
5. Completing Quality walkdowns of the area.
6. Participates as a key quality member in inspections and audits of JSCI by external parties/agencies.
General QA Description
Position Summary:
This position is responsible for carrying out tasks and projects related to 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.
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. Administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
3. Management of batch records design and approval.
4. Administration of the SAP Quality Management Module.
5. Management of 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. Co-ordinate and assist in the preparation for regulatory and customer GMP inspections of the site.
12. Participate in the introduction of new process 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. Perform on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards.
15. Administration of site supplier approval process.
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.
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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