About the Role
We are hiring a QA Specialist for a leading pharmaceutical biologics client. This role offers an exciting opportunity to contribute to the assurance of quality standards in biologics manufacturing. The ideal candidate will bring 3+ years of experience in pharmaceutical quality assurance, with a strong emphasis on GMP compliance, batch record review, and regulatory readiness.
Key Responsibilities
- Batch Record Review (BMRs): Review and approve batch records, ensuring that all documentation is complete and accurate. Handle deviations and discrepancies, ensuring they are properly documented, investigated, and resolved.
- Deviation Management: Manage and investigate deviations, ensuring corrective and preventive actions (CAPA) are implemented to resolve quality issues.
- Change Control: Support and manage change control processes to ensure all changes are evaluated, documented, and approved in compliance with GMP requirements.
- Quality Systems & Compliance: Oversee quality systems activities such as cleaning validation, documentation reviews, and ensuring ongoing audit readiness.
- Regulatory Inspections: Support preparations for regulatory inspections (FDA, EMA, NPRA, etc.), ensuring all documentation and processes are in compliance with regulatory requirements.
- Data Integrity: Apply data integrity principles (ALCOA/ALCOA+) to maintain the reliability, completeness, and accuracy of all data within QA processes.
Requirements
- 3+ years of experience in a QA role within the pharmaceutical biologics industry, with hands-on experience in batch record review, deviation management, and CAPA processes.
- Strong understanding of GMP guidelines, quality systems, and compliance activities.
- Familiarity with regulatory inspections and experience in preparing for or supporting audits (FDA, EMA, NPRA, etc.).
- Knowledge of data integrity principles (ALCOA/ALCOA+) and demonstrated ability to apply them in QA operations.
- Excellent attention to detail with strong problem-solving skills and the ability to handle complex compliance challenges.
