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GMP Compliance Specialist
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Randstad is partnering with a global pharmaceutical and biotechnology company. This role will be responsible for enabling GMP production of sterile drug product manufactured at the Norwood site. Specifically, the role will be tasked with performing deviation investigations, root cause analysis and CAPA management. Additionally, the role will be accountable to coordinating and monitoring performance metrics around deviation performance. This role will work cross functionally with Engineering, MS&T and Quality Assurance partners to ensure a culture of continuous improvement and right first time are imbedded in day-to-day operations.
Key Responsibilities and if appropriate Authorities of the Position:
- GMP Documentation: Write, review, and approve deviation investigation and CAPA plans.
- Monitor CAPA completion progress and provide support to stakeholder departments to ensure on-time completion.
- Identify and coordinate continuous improvement opportunities across the department.
- Metrics and Reporting: Generate targeted metrics for Quality Management Review and support data collection for regulatory filings.
- Regulatory Compliance: Ensure operational compliance with relevant FDA, EU, ICH guidelines, and regulations.
(Must Have) Required Background:
- Experience (Sr. Specialist): Science or Engineering background (B.S.) with 5+ years of experience or MS with 3+ years of experience in a pharmaceutical or biotechnology company.
- Experience (Specialist): Science or Engineering background (B.S.) with 3+ years of experience or MS with 2+ years of experience in a pharmaceutical or biotechnology company.
- Other Quantifiable Preference: Experience in biopharmaceutical & GMP.
