QA Specialist - Compliance

Key Responsibilities:

1. Regulatory Compliance: Interpret and ensure compliance with national and international regulatory requirements and industry standards, including GMP and ISO.

2. Quality Audits: Plan, conduct, and lead quality audits to evaluate the effectiveness of quality systems and adherence to established procedures.

3. Quality Documentation: Oversee and maintain a comprehensive system for document control, including SOPs, batch records, and quality records.

4. Change Control: Manage and document changes to quality systems, processes, and procedures, ensuring thorough evaluation and compliance with regulatory standards.

5. Training and Development: Provide training and support to employees regarding quality standards, regulatory requirements, and best practices.

6. CAPA Management: Lead investigations into deviations, non-conformities, and incidents, implementing corrective and preventive actions (CAPAs) to prevent recurrence.

7. Risk Assessment: Identify and assess potential risks in operational processes, working to mitigate and manage them effectively.

8. Quality Reporting: Generate and present reports on quality performance, deviations, and compliance to management and regulatory bodies as required.

Qualifications:

• Bachelor's or Master's degree in a relevant life sciences or quality management field.
• A minimum of [X] years of experience in quality assurance with a focus on regulatory compliance, preferably in the biotech or pharmaceutical industry.
• In-depth knowledge of regulatory requirements and quality standards, including GMP, ISO, and industry-specific regulations.
• Strong analytical, problem-solving, and communication skills.
• Experience in quality audits and change control is highly desirable.

Can this be interesting for you or anyone you know? If so, please apply here or contact Conor Kelly with your number/CV ASAP and he will give you a call.

?: +41 (0) 44 5514 407

?: c.kelly@panda-int.com