Quality Assurance Associate

Job Summary

We are seeking an experienced QA Associate to join our quality team. In this role, you will ensure that product and process-related investigations, complaints, batch review, and batch release activities are performed on time and in compliance with GMP requirements. You will collaborate closely with cross-functional teams and external partners/subcontractors to maintain product quality, regulatory compliance and inspection readiness.

The ideal candidate is an experienced Quality Assurance professional with a strong background in pharmaceutical manufacturing and a thorough understanding of GMP requirements and quality systems. The successful candidate combines strong analytical skills, attention to detail, and effective communication skills to collaborate across internal teams and with external partners/subcontractors. Through a proactive and quality-focused approach, the QA Associate contributes to maintaining the highest standards of product quality, regulatory compliance and customer satisfaction.

Key Responsibilities

Training delivery: support in the development and delivery of GMP introduction training for new employees and/or other quality-related training sessions (e.g. deviations, CAPA, documentation practices), to ensure personnel understand and comply with current Good Manufacturing Practices and internal quality procedures.

Support in investigations: Provide guidance in the timely and thorough investigation of deviations, complaints, OOS/OOT results, and other quality-related issues, ensuring accurate documentation and appropriate follow-up actions.

Deviations and complaints management: Ensure that deviations and customer complaints are recorded, investigated and resolved in a timely and compliant manner. Escalate issues that could have significant impact product quality, regulatory compliance or patient safety.

CAPA management: Coordinate and track the implementation of Corrective and Preventive Actions (CAPAs) to address root causes identified through investigations. Monitor CAPA effectiveness and ensure timely closure.

Audit/Inspection support: Support the preparation, execution, and follow-up of internal audits, regulatory inspections, and customer quality audits. Assist in maintaining a state of inspection readiness and responding to audit observations.

Support in change management : Provide input and support for change management processes, including reviewing and assessing proposed changes for potential quality and compliance impact.

Batch documentation review : Review batch manufacturing records, packaging records and QC documentation to confirm compliance with internal procedures and regulatory requirements prior to product release.

Supplier/Subcontractor Qualification & management:

Support the qualification, evaluation and monitoring of suppliers and service providers to ensure they meet regulatory and company quality standards. Participate in supplier audits, review supplier documentation (e.g. questionnaires, certifications, audit reports, incidents, deviations, change notifications, ...) and help maintain the approved supplier list.

Collaboration and stakeholder engagement : Build and maintain strong cross-functional relationships with internal departments (e.g.,Manufacturing, QC, Engineering, Logistics,.... and external partners to ensure alignment on quality standards and expectations.

Team Support and backup : Act as a backup for other QA team members, providing support during absences or peak workload periods. Contribute to team goals and continuous improvement initiatives.

Continuous Improvement : Identify opportunities to improve quality systems, processes, and procedures while supporting the implementation of efficiency and compliance enhancement.

Profile

• Bachelor degree in Life Sciences, Chemistry, Engineering, or a related field
• Minimum 5 years of experience in a Quality Assurance role within the pharmaceutical industry.
• Strong understanding of regulatory requirements and quality systems.
• Knowledge of risk management tools and methodologies (e.g. FMEA).

Skills and Competencies

• Excellent organizational skills.
• Excellent attention to detail and analytical skills.
• Strong written and verbal communication skills.
• Ability to work independently in a collaborative team environment.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Quick learner and able to work in a fast-changing environment
• Willingness to work in a nuclear and pharmaceutical controlled environment with adherence to strict safety and regulatory protocols.