Responsibilities :

Validation Planning and Strategy : Develop and implement validation plans and strategies in alignment with current Good Manufacturing Practices (cGMP), FDA, EMA, and other regulatory guidelines.

Commissioning, Qualification, and Validation (CQV) : Lead and execute CQV activities for manufacturing equipment, facilities, and processes, ensuring they meet predefined specifications and quality attributes.

Installation Qualification (IQ) and Operational Qualification (OQ) : Perform IQ and OQ activities, ensuring equipment and systems are installed and functioning according to manufacturers' specifications and industry standards.

Performance Qualification (PQ) and Process Performance Qualification (PPQ) : Oversee PQ and PPQ to demonstrate that processes operate in a state of control and meet product quality specifications.

Protocol Authoring and Execution : Develop, review, and execute validation protocols and reports, including but not limited to, risk assessments, test scripts, and validation summaries.

Change Control and Deviation Management Manage change control processes and investigate deviations from established processes or outcomes, implementing corrective actions as necessary.

Collaboration and Coordination Work closely with cross-functional teams, including engineering, quality assurance, manufacturing, and regulatory affairs, to ensure alignment of validation activities with project goals.

Regulatory and Quality Compliance Ensure all validation activities and documentation comply with regulatory requirements and quality standards, preparing for and supporting regulatory inspections and audits.

Requirements :

Bachelor's degree in Engineering, Science, or related field.

Extensive experience in validation within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing.

Strong understanding of cGMP, FDA, EMA, and other regulatory requirements.

Proficient in the principles and practices of process validation, equipment qualification, and cleaning validation.

Excellent analytical, problem-solving, and decision-making skills.

Exceptional communication and collaboration abilities to work effectively with all levels of the organization and cross-functional teams.

Last updated : 2024-05-20