freiberufler Regulatory Affairs, Project Management, Process Excellence and Quality, Lean Six Sigma auf freelance.de

Regulatory Affairs, Project Management, Process Excellence and Quality, Lean Six Sigma

offline
  • 1€/Stunde
  • 28199 Bremen
  • auf Anfrage
  • hi  |  en  |  de
  • 29.11.2020

Kurzvorstellung

12 years experience in Pharmaceutical and CRO. Skilled in Regulatory submissions. Quality & Project Management, Traning, Risk assessment, RCA, CAPA, Client Audits, Regulatory Inspection, Quality Issue management RIMS, VeevaVault, QuIPS, TrackWise,

Qualifikationen

  • Good Manufacturing Practices
  • Projektmanagement4 J.
  • Projektmanagement - Audits3 J.
  • Regulatory Affairs11 J.
  • Six sigma8 J.
  • Total-Quality-Management8 J.

Projekt‐ & Berufserfahrung

Process Excellence and Quality Specialist II Senior Regulatory Affairs Associate (Festanstellung)
PAREXEL International, Bengaluru
6/2015 – 1/2020 (4 Jahre, 8 Monate)
Life Sciences
Tätigkeitszeitraum

6/2015 – 1/2020

Tätigkeitsbeschreibung

• Compilation, review and regulatory submission (MAA, renewals, variations) in EU and other international markets
• Respond to deficiency letter from health authorities
• Creation and maintenance of submission plans
• Coordinate with local experts to obtain Regulatory Intelligence for clients
• Responsible for maintenance of registration databases
• Coordinate with project teams for Risk Management
• Plan regulatory project forecast and budget
• Conduct root cause analysis and determine CAPA for RA Quality Issues
• Prepare and effectively manage project teams for client audits and regulatory inspections
• Develop Quality Control process for RA activities based on client KPI
• Develop and update written standard methodologies for regulatory deliverables

Eingesetzte Qualifikationen

Regulatory Affairs, Projektmanagement, Six sigma, Total-Quality-Management

Regulatory Affairs Associate II (Festanstellung)
Apotex, Bengaluru
2/2012 – 5/2020 (8 Jahre, 4 Monate)
Life Sciences
Tätigkeitszeitraum

2/2012 – 5/2020

Tätigkeitsbeschreibung

• Preparation, review and submission of regulatory documents (CTD Modules 1, 2 and 3) for world wide registrations
• Handling of regulatory deficiencies and product CMC life cycle management
• Liaison with other departments for project management
• Coordination for manufacturing license applications
• Notification of the changes to regulatory authorities and customers
• Review documentation of quality management system

Eingesetzte Qualifikationen

Regulatory Affairs

Junior Manager (Festanstellung)
Dr. Reddy’s Laboratories, Hyderabad
10/2008 – 1/2012 (3 Jahre, 4 Monate)
Life Sciences
Tätigkeitszeitraum

10/2008 – 1/2012

Tätigkeitsbeschreibung

• Preparation, submission and review of DMF in conformance with the regulatory requirement for US, Europe, Canada and ROW in eCTD, paper submission, NeeS format, Single PDF
• Liaison with other departments for submission /deficiencies documents
• Review of Change Controls and Deviations
• Support regulatory inspections (USFDA, MHRA, KFDA)
• Review customer agreement in coordination with legal department
• Deliver training sessions on regulatory submission requirements
• Involved in organisational improvement projects - Lean Six Sigma, Yield improvement analysis, Cp, Cpk calculation and value stream mapping

Eingesetzte Qualifikationen

Regulatory Affairs, Projektmanagement - Audits, Six sigma, Total-Quality-Management

Ausbildung

Certification
Ausbildung
2011
Six Sigma Green Belt
Masters
Total Quality Management
2008
Indien
Masters
Biochemistry
2006
Indien

Persönliche Daten

Sprache
  • Englisch (Fließend)
  • Deutsch (Grundkenntnisse)
  • Hindi (Muttersprache)
Reisebereitschaft
auf Anfrage
Arbeitserlaubnis
  • Europäische Union
Profilaufrufe
1284
Alter
41
Berufserfahrung
16 Jahre und 1 Monat (seit 10/2008)
Projektleitung
12 Jahre

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