freiberufler Quality and Validation auf freelance.de

Quality and Validation

offline
  • auf Anfrage
  • 4537 Wiedlisbach
  • National
  • en  |  de
  • 17.02.2019

Kurzvorstellung

An experienced consultant with a solid background in quality management systems and regulatory requirements (ISO & cGMP (21CFR 211/820/600 and EU directives for design manufacture and distribution of pharmaceuticals and medical devices

Ich biete

  • Microsoft Access

Projekt‐ & Berufserfahrung

Subject matter expert
J & J / Du Puy Synthes, Oberdorf
3/2014 – 12/2014 (10 Monate)
Life Sciences
Tätigkeitszeitraum

3/2014 – 12/2014

Tätigkeitsbeschreibung

GDP Assisting J&J to bring on line a new secondary supply company for the distribution of pharmaceutical and over the counter products to the DACHS group countries.

Legacy review and remediation of process validation and monitoring discrepancies. (Working in German and English)

Eingesetzte Qualifikationen

Access

Zertifikate

Chemistry with environmental studies
Juni 1982

Ausbildung

Chemie

(BSc)
Jahr: 1982
Ort: Salford

Qualifikationen

BSc
MCQI
CQP
MS Office / SAP / Agile /

Über mich

An experienced consultant with a solid background in quality management systems and regulatory requirements (ISO & cGMP (21CFR 211 / 820/600 including part 11 and EU directives for design manufacture and distribution of pharmaceuticals and medical devices).Design controls and Industrial processes for Chemical and Biochemical production and distribution of pharmaceuticals medical devices and vaccines. Management tools, (BPR, MPR/MPRII, SAP, TEDI) manufacturing techniques, and quality management tools such as SPC, Pareto, Continuous improvement (Kaizen), Risk Management and FMEA, JIT, Kanban, Lean Manufacturing, 6 Sigma, and 5 Pillars / 5S. Experienced in the commissioning; validation and verification of complex process equipment for primary and secondary processing in Bio-pharm Pharmaceutical and Medical devices including validation of computer systems, Invitro Diagnostic Devices and Laboratory equipment and methods. Validation of instruction for use by human factors engineering studies

Persönliche Daten

Sprache
  • Englisch (Muttersprache)
  • Deutsch (Fließend)
Reisebereitschaft
National
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
1011
Alter
68
Berufserfahrung
50 Jahre und 3 Monate (seit 06/1972)
Projektleitung
20 Jahre

Kontaktdaten

Nur registrierte PREMIUM-Mitglieder von freelance.de können Kontaktdaten einsehen.

Jetzt Mitglied werden