Job Description
Quality Assurance Specialist sought to support Maintenance Department at Janssen in Cork, Ireland, with expertise in Good Manufacturing Practice (GMP) and regulatory compliance.
Kenny-Whelan, a specialist division of the CPL group, is hiring a Quality Assurance Specialist to work on contract at Janssen in Ringaskiddy, Cork. This role is responsible for managing Quality Assurance activities, including incoming material release, batch release, change control, event management, supplier qualification, and validation compliance.
The successful candidate will provide support and direction to all departments to ensure business, quality, and compliance goals are met. Key responsibilities include:
- Batch Record Review & material release to ensure compliance with GMP requirements.
- Administer event management systems, including Review & Approval of Events, Deviations, and Customer complaints.
- Manage batch records design and approval.
- Administer the SAP Quality Management Module.
- Manage site change control systems.
- Compile Annual Product Reviews.
- Support all validation activities on site as described in the Site Validation Master Plan.
- Approve and compile validation protocols and reports.
- Support system qualification and process validation activities.
- Review and approve SOPs/work instructions/forms from other departments.
- Coordinate and assist in the preparation for regulatory and customer GMP inspections.
- Participate in the introduction of new or modified process steps.
- Perform GMP audits on-site and vendor facilities.
- Conduct regular walkdowns to ensure process and facilities are maintained to GMP standards.
- Administer site supplier approval process.
Key skills and competencies required:
- Excellent interpersonal skills.
- Ability to operate as part of a team.
- Customer focus.
- Innovative.
- Excellent communication skills.
- Attention to detail.
- Good problem-solving skills.
- Results and performance-driven.
- Adaptable and flexible.
- Decision making.
Qualifications and experience:
- Bachelor's Degree in a scientific/technical discipline.
- A minimum of 3-5 years' experience in a quality, validation, or compliance role within the biological and/or pharmaceutical industry.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Demonstrated knowledge and application of industry regulations.
Desirable:
- Experience in auditing of external suppliers, contractors, and vendors.