Job Description
The role of Senior Validation Specialist plays a pivotal part in ensuring the ongoing validation and compliance of existing and new equipment, systems, and processes. This entails designing, executing, and reporting on Process Performance Qualifications (PPQs) for equipment, systems, and processes.
Responsibilities:
1. Developing and implementing validation strategies for equipment, systems, and processes to ensure they meet regulatory requirements.
2. Maintaining accurate and up-to-date validation documentation throughout the validation lifecycle.
3. Providing technical guidance on current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
4. Collaborating with cross-functional teams to resolve validation-related issues and implement corrective actions.
Qualifications:
* Bachelor's degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Mechanical, Chemical, Electrical).
* Minimum 3-5 years of experience working in a healthcare manufacturing environment, preferably in the pharmaceutical sector.
* Strong understanding of process validation regulations, industry practices, and guidelines.
Candidates should possess excellent problem-solving skills, attention to detail, and effective communication skills. Previous experience in validation/product development would be highly advantageous for this role. Knowledge of GAMP, ISPE Baseline guides, AAMI/ANSI, PDA, and ISO guidelines is essential. Key Skills: NPI Equipment Qualification, Process Performance Qualifications, PV.
Key Skills
* NPI Equipment Qualification
* Process Performance Qualifications
* PV