Our client is a prominent biotech company, known for its innovations in the field of rare diseases. They are currently seeking a dynamic Quality Assurance Operations Specialist to join their growing team in Switzerland.
Key Responsibilities:
- Regulatory Compliance: Implement, monitor, and maintain the quality management system to ensure compliance with regulatory requirements, including GMP and ISO standards.
- Operational Excellence: Collaborate with cross-functional teams to streamline and optimize operations, driving efficiency while maintaining the highest standards of quality.
- Audits and Inspections: Prepare for and assist with internal and external audits, ensuring adherence to compliance standards and addressing any findings or discrepancies.
- Documentation Control: Oversee document management, including SOPs, batch records, and quality records, to guarantee accuracy, completeness, and compliance.
- Risk Management: Identify and assess potential risks in operational processes, working to mitigate and manage them effectively.
- Training and Development: Provide training and support to employees regarding quality standards, procedures, and best practices, ensuring a culture of quality awareness.
- Deviation and CAPA Management: Lead investigations into deviations, non-conformities, and incidents, implementing corrective and preventive actions (CAPAs) to prevent recurrence.
- Change Control: Manage change control processes to assess and approve changes in operations and maintain compliance.
Qualifications:
- Bachelor's or Master's degree in a relevant life sciences discipline.
- Minimum of 5 years of experience in quality assurance within the biotech or pharmaceutical industry, with a focus on oncology.
- In-depth knowledge of regulatory requirements and quality standards, specifically in the field of oncology.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal abilities.
- Experience with document control and audit preparation is a plus.
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