Requirements :
Advanced degree in chemistry, biology, chemical engineering or similar field of study.
Knowledge of sterile drug product primary pack & devices, qualification process
Project management skills and validation technical skills
Experience with at least 2–6 year primary pack & devices qualification for a Pharmaceutical or Biopharmaceutical company.
Ability to resolve complex technical issues by bringing creative solutions with the right quality framework
Knowledge and understanding of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and ISO standards.
Hands on mentality/approach and ability to work in the laboratory.
Flexibility to face rapidly changing environment
Ability to work in a matrix international organization.
Proficiency in writing DSR, FMEA, URS, DQ, VMP, IOQ, VSR, qualification protocol, extractable protocols, biocompatibility reports, and leachable risk assessments and PES calculation.
Written and oral fluency in English.
Excellent communication and negotiation skills.
Preferred Qualifications:
Competent in use of templates and forms
Strong skills in Microsoft Excel, Microsoft Office, and PowerPoint
Good understanding of good manufacturing practices
Ability to understand technical processes
Excellent communication skills
Ability to train and coach others