Our client, a prominent biotech company at the forefront of their field, are currently, seeking a skilled and dedicated QA External Quality Specialist to join their team.
Key Responsibilities:
- External Partner Oversight: Collaborate with external partners and suppliers to establish and maintain quality agreements, ensuring alignment with our quality standards and regulatory requirements.
- Quality Audits: Plan and conduct quality audits of external partners, including vendors and contract manufacturers, to assess compliance with quality standards and regulations.
- Risk Assessment: Identify and evaluate potential risks associated with external partners and their impact on product quality, initiating risk mitigation strategies.
- Quality Agreements: Develop and maintain quality agreements, specifications, and standards to ensure that external partners adhere to our quality requirements.
- Documentation Control: Oversee and optimize document management for external quality, including the review and approval of quality-related documents.
- Deviation and CAPA Management: Lead investigations into deviations and non-conformities related to external partners, ensuring the implementation of corrective and preventive actions (CAPAs).
- Regulatory Compliance: Ensure external partners' adherence to regulatory standards, including GMP and ISO requirements.
Qualifications:
- Bachelor's or Master's degree in a relevant life sciences or quality management field.
- A minimum of 5 years of experience in quality assurance, with a focus on external quality management within the biotech or pharmaceutical industry.
- Profound knowledge of regulatory requirements, quality standards, and best practices specific to external quality management.
- Strong analytical, problem-solving, and communication skills.
- Experience in quality audits and working with external partners 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