QA - Expert (CAPA) (m/f)

REFERENZNUMMER:

242515/11

IHRE AUFGABEN:

-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
-Batch record review
-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, runsheets, material specification, etc.)
-Reports any potential issues detected on the floor and proposes adequate Corrective and Preventive Actions
-Establishes efficient partnership with Production people to define and review detailed action plan for any process modification or improvement
-Participates and/or leads meetings with Production
-Perform quality control as required during Operations (Production or Validation)

IHRE QUALIFIKATIONEN:

-Education level: BA / Ma Scientific degree: see below, linked to requested experience
-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
-We are looking for a strong energetic team player with good communication skills, capable of dealing with complex and divers situations

WEITERE QUALIFIKATIONEN:

Quality assurance manager