Sr Process Validation Consultant
We are currently seeking a highly skilled and experienced Senior Consultant to support one of our key pharmaceutical clients in the validation of Fill & Finish processes. This role is critical to ensuring that aseptic manufacturing operations meet the highest standards of regulatory compliance, product quality, and operational efficiency. The ideal candidate will bring a deep understanding of Good Manufacturing Practices (GMP) and extensive experience in process validation, particularly within sterile and aseptic environments.
Key Responsibilities
- Lead the planning, execution, and documentation of validation activities for Fill & Finish processes, including aseptic filling, lyophilization, and terminal sterilization.
- Draft, review, and approve validation protocols, risk assessments, and final reports in alignment with regulatory expectations.
- Ensure that all validation activities comply with international regulatory standards (FDA, EMA, ICH) and internal quality systems.
- Collaborate closely with cross-functional teams including production, quality assurance, engineering, and tech transfer to ensure seamless execution of validation projects.
- Support technology transfer activities, ensuring robust process design and knowledge transfer from development to commercial scale.
- Identify, investigate, and resolve process-related issues, deviations, and non-conformances in a timely and compliant manner.
Key Competencies & Experience
- Demonstrated expertise in technology transfer and New Product Introduction (NPI) within aseptic Fill & Finish operations.
- Strong working knowledge of GMP, Annex 1, and regulatory requirements for sterile manufacturing.
- Proven ability to develop and execute comprehensive validation strategies and documentation.
- Excellent analytical, problem-solving, and project management skills.
- Effective communicator with the ability to work collaboratively across multidisciplinary teams.
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