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Job Description
Quality Assurance Specialist sought for 11-month contract in Dublin North, ensuring adherence to Good Manufacturing and Documentation Practices.
The role involves providing quality coaching and guidance on the shop floor, reviewing and approving GMP documentation, and supporting compliance and data integrity.
Job Description
The Quality Assurance Specialist will ensure adherence to Good Manufacturing and Documentation Practices, Quality Manual and local procedures.
- Provide direct Quality support to production and support areas.
- Review and approve GMP documentation/data for accuracy and completeness.
- Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures.
- QA support, review and approval of C&Q, Performance qualification (PQ) & Process Validation documents.
- Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance & Calibration Programs.
- Provides support to internal audits and regulatory inspections.
- Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.
Qualification and Experience:
- Bachelor degree in a scientific or engineering field.
- 3 years of relevant post-degree experience in a GMP environment: manufacturing, laboratory, quality, operations, technical, or regulatory function.
- MES experience is desirable.
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment.
- Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field.
- Technical writing skills.
- Lean Six-sigma and problem-solving tools.