QA Validation Consultant - Pharma

QA Validation Consultant 
 

For one of our clients, a multinational pharmaceutical and biotechnology company, we are actively looking for a QA Validation Consultant. 

Purpose of the Mission 

Provide QA support and oversight to validation activities according to validation procedures. 

Key Responsibilities 

• Provide a compliance expertise in validation 
• Ensure QA oversight in validation activities (IQOQ / PQ / PV…) 
• Review/Approve the validation documentation regarding the GMP requirements and the company’s Vaccines procedures 
• Ensure that production practice are aligned with validation conclusion 
• Attend all project meetings as QA validation representative 
• Ensure timely escalation to Management of critical issues during validation 
• Contribute to the deviation process providing QA oversight and reviewing deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities (Approval must be performed by internal employee) 
• Pro-actively identify potential quality and compliance  
• Work in autonomy with supervision/coaching 
• To define the validation strategies through the change control process. 
• To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis, Periodic review ….) 
• To ensure the correct application of the validation quality systems in the field and to define improvement plan as required 
• To support the production, QA and technical service teams in the implementation of the validation activities 

Experience: 

Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry. 
Knowledge of GMP / CFR / EudraLex … 
Knowledge of different regulations and standards related to validation activities 
 
Soft skills: 

Good interpersonal relationship skills 
Problem solving and achievement oriented 
To be a good team player in order to succeed in each validation project and routine activities 
To be able to use a risk-based approach for problem solving and prioritization of tasks 
 
Knowledge: 

SAP, documentum is an asset. 
 
Education: 

University degree (Biotechnology, Agronomy, Chemistry or Pharmacy) 
 
Language Proficiency Requirements 

French - Fluent oral and written communication skills 
English - Good oral and written communication skills