Beschreibung
For our major client, we are looking for contract resources (locations: BL, SO, BE, TI etc.) as
LEGACY REVIEW SPECIALISTS
Job description/Functional experience requirements:
With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.). Audit sites' procedures to the standards and report out on findings (both current state and retrospectively. Make recommendations to achieve compliance where shortfalls are found. Provide Audit reports as directed. Perform CAPA root cause and corrective/preventive action as necessary. Perform CAPA verification of effectiveness as necessary. Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines. Analysing reports NCR, CAPA files. Analysing inspection activities. Analysing maintenance reports and monitoring data. Bringing in of improvement proposals, which increase the productivity and efficiency of manufacturing and facility and operational practices. Consultancy and guidance of all employees regarding maintenance, NCR, CAPA etc. Knowledge & Skills:
The resource should be versed in the process validation methodology, NCR, CAPA, inspection and calibration, as defined by GAMP, AAMI, ASQ, DePuy or Legacy. The person must be analytical, thorough, accurate and proficient in the use of computers. Manufacturing processing background is required, as the special processes are generally not verifiable; thus, the validation requirement. The resource must be proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters The resource should have the ability to travel, to perform internal audits and be able to work independently - with minimal supervision Degree as an Engineer (Mechanical) Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS, SAP etc.). Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines. Fluently German/English spoken and written Experience:
Minimum of 5 years quality/compliance experience in the medical device or pharmaceutical industries. Prior experience in medical device/pharmaceutical remediation preferred. Familiarity and interaction experience with regulatory auditing bodies preferred. Documented training in FDA QSR, ISO required. Proficient in the use of spread sheet software (Access/Excel etc.). Solid knowhow of FDA QSR, ISO 13485 Are you interested in this position? We are looking forward to receive your application. Many thanks.
