QA Expert (CAPA) (m/f)

West Switzerland  ‐ Onsite
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Keywords

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
Start date
ASAP
Duration
6 MM++
(extension possible)
From
Hays AG
Published at
12.06.2014
Contact person:
Kerstin Sieber
Project ID:
725356
Contract type
Freelance
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