QA Specialist
5 hours ago
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.
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.
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