QA Associate - Sterile Fill Start-Up (Contract)

biomarin; Cork; On-site; EUR 52,000 - 72,000; Full time

Job summary

BioMarin is a leading biotechnology company focused on rare diseases. This QA Associate contract role at the Shanbally facility offers a start-up environment with a 12-month term, working 3 days on, 3 nights, 2 days, 2 nights in a rotating shift, with hours from 6am-6pm and 6pm-6am.

The successful candidate will provide QA support for start-up and routine QA activities, ensure GMP compliance, oversee documentation, CAPA management, and drive continuous process improvement across sterile filling

Qualifications

• Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
• Demonstrated experience in Sterile Drug Product Filling and start-up of same.
• 5+ years in QA in pharmaceutical/biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
• Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
• Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels.
• Proficiency in PC skills such as Excel, Word, PowerPoint.
• Proven decision making capability with full accountability and responsibility.
• Demonstrated coaching skills.
• Excellent written and verbal communication skills.
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations.

Responsibilities

• Provide Quality direction and oversight of the start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations.
• Provide Quality input to Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely.
• Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with BioMarin Policies.
• Participates within inter‑departmental and cross‑functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved.
• Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
• Provide Quality input to Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
• Exercise judgment to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation and corrections.
• Pro-actively identifies compliance risks and takes appropriate preventative actions.
• Proactively identify potential issues, lead root cause analysis, make recommendations and aid in implementation for more complex and non-reoccurring issues.
• Ensure high level of Quality / cGMP Awareness in the Project Team and Sterile Filling Team.
• Lead Area GMP Certification Activities.
• Support pre‑approval Regulatory Inspection readiness to ensure regulatory approvals are obtained.
• Support all Quality Assurance elements needed to facilitate new product launches.

Skills

Attention to detail

Communication skills

Organizational skills

Problem solving

Team collaboration

Education

Science/Quality degree

QP Qualification

Tools

Excel

Word

PowerPoint

Job description

BioMarin is a leading biotechnology company focused on rare diseases. This QA Associate contract role at the Shanbally facility offers a start-up environment with a 12-month term, working 3 days on, 3 nights, 2 days, 2 nights in a rotating shift, with hours from 6am-6pm and 6pm-6am.

The successful candidate will provide QA support for start-up and routine QA activities, ensure GMP compliance, oversee documentation, CAPA management, and drive continuous process improvement across sterile filling