Safeguarding clinical quality through precision, compliance, and unwavering attention to detail.
Proclinical is seeking a QA Associate to support quality assurance activities within a GMP/GDP environment. This role focuses on ensuring compliance with EU regulations and maintaining high standards in clinical trial operations. You will collaborate with internal teams and external stakeholders to uphold quality processes and documentation.
Responsibilities:
- Assist the Qualified Person in preparing QP Declarations and Certificates, including supply chain diagrams, product specifications, and regulatory document reviews.
- Facilitate 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 presentations within electronic systems.
- Conduct internal SOP training, track employee training records, and deliver periodic GXP training sessions.
- Participate in internal, supplier, client, and regulatory audits.
- Review and archive preventative maintenance documentation and calibration files.
- Oversee instrument identification, calibration, and maintenance processes, including investigations for out-of-tolerance or retired instruments.
- Maintain GMP/GDP documentation storage, both manually and electronically.
- Provide QA support for GMP/GDP activities such as receiving, storing, distributing, and processing products.
- Perform incoming quality control inspections, packaging room activities, and quality control for shipments as needed.
- Verify returns for accountability and manage inventory control system data.
- Approve material specifications and batch record-related documents, including packaging samples.
- Release products and clinical labels while monitoring expiration dates and authorizing materials for destruction.
- Conduct weekly logbook reviews and investigate operational discrepancies and client complaints.
- Maintain supplier approval records and oversee CAPA program implementation and tracking.
- Support risk assessment programs and change control procedures for documentation and systems.
- Review facility temperature records and assist with validation activities and quality metrics generation.
- Evaluate new products for handling or use and approve packing configurations and qualification reports for insulated shipping containers.
- Review and approve materials for interoffice shipping requests.
Key Skills and Requirements:
- Experience in a GMP environment supporting global clinical trials.
- Familiarity with QA manufacturing support, particularly for sterile, biotech, or vaccine products.
- Bachelor's degree or equivalent in a related field.
- Strong understanding of GMP, GDP, and GCP in the pharmaceutical industry.
- Excellent communication, reading, writing, and problem-solving skills.
- Proficiency in mathematics and computer literacy.
- Attention to detail and effective time management skills.
- Ability to adapt to changing workloads and deadlines.
- Strong interpersonal skills and ability to work in a diverse community.
If you are having difficulty in applying or if you have any questions, please contact Ingrid Wilson at i.wilson@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy
