QA Associate

Are you passionate about quality, compliance, and clinical trial excellence, with a desire to make a meaningful impact in the pharmaceutical industry?

Proclinical is seeking a QA Associate to support quality assurance activities and ensure compliance with EU GMP/GDP standards. This role involves working closely with internal teams and external stakeholders to maintain high-quality standards in pharmaceutical operations. You will play a key role in supporting clinical trials and ensuring the integrity of processes and documentation.

Responsibilities:

• Assist the Qualified Person in preparing QP Declarations and Certificates, including supply chain diagrams, product specification files, and regulatory document reviews.
• Participate in client and departmental meetings.
• Support recall processes by gathering information, preparing documentation, and performing accountability checks.
• Generate, revise, and review Standard Operating Procedures (SOPs), Data Capture Forms, and other GMP/GDP documents.
• Manage SOPs, forms, work instructions, and training materials within electronic systems.
• Conduct internal SOP training, track employee training, and maintain training records.
• Create and deliver periodic GXP training sessions.
• Perform or participate in internal, supplier, client, and regulatory audits.
• Review and archive preventative maintenance documentation.
• Manage instrument calibration, maintenance, and related investigations.
• Maintain GMP/GDP documentation, including scanning, filing, and archiving.
• Provide QA support for GMP/GDP activities such as receiving, storing, distributing, and processing products.
• Conduct incoming quality control inspections and packaging room activities as needed.
• Verify returns for accountability and oversee inventory control system data entry.
• Approve material specifications and batch record-related documents.
• Release products and clinical labels, monitor expiration dates, and authorize material destruction.
• Review logbooks weekly and investigate operational discrepancies and complaints.
• Maintain supplier approval records and support CAPA program development and tracking.
• Ensure proper change control procedures for documentation and systems.
• Oversee GMP/GDP risk assessments and validation activities.
• Generate quality metrics and review new products for handling suitability.
• Approve packing configurations and qualification reports for insulated shipping containers.
• Review and approve materials for interoffice shipping requests.

Key Skills and Requirements:

• Strong understanding of GMP and GDP standards in the pharmaceutical industry.
• Familiarity with GCP in clinical trials.
• Excellent communication, reading, writing, and problem-solving skills.
• Proficiency in computer literacy and attention to detail.
• Effective time management and adaptability to changing workloads and deadlines.
• Ability to work collaboratively in a diverse team environment.
• Experience in a GMP environment supporting global clinical trials.
• Previous QA manufacturing support experience, particularly with sterile, biotech, or vaccine products.
• Bachelor's degree or equivalent in a relevant field.

If you are having difficulty in applying or if you have any questions, please contact Ingrid Wilson at i.wilson@proclinical.com.

Apply Now:

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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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