Description
We are looking for a
QA Expert (CAPA) (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in West Switzerland
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Serve as a change agent for the area and review change requests according to processes, quality systems and applicable regulatory files
- Assist, review, and prepare approval and timely closure of all changes including emergency changes
- Review and approve documents in direct partnership with production and quality engineering
- Review batch records according to existing procedures and guidelines/regulations
- Verify in-process critical manufacturing steps and calculations during working hours
- Lead investigations, root cause analysis, corrective and preventive actions, and closure of exception management documentation in a timely manner
- Develop and implement appropriate tools and methods to perform standard investigation and problem-solving techniques, to close exception documents, and to ensure appropriate adherence to quality documents (procedure, run sheets, material specification, etc.)
- Report any potential issues detected on the floor and propose adequate Corrective and Preventive Actions
- Establishe efficient partnership with production people to define and review detailed action plan for any process modification or improvement
- Participate and/or lead meetings with production
- Perform quality control as required during operations (production or validation)
Your qualifications
- BA/Ma scientific degree
- CGMP and regulatory requirements working knowledge
- Good writing skills and good knowledge of French and English, written and spoken
- Good computer skills (MS office)
- Good communication and negotiating skills
- Good organizational skills, precision and rigor
- Good analytical and problem solving skills
- Strong energetic team player with good communication skills, capable of dealing with complex and divers situations
Skills:
- Quality assurance manager
Keywords: Quality Assurance Manager