Engineering Specialist
1 week ago
Job Description
We are seeking a highly skilled GMP Validation Professional to join our team at Claran Consultants Ltd. This is an exciting opportunity for candidates interested in a new challenge in a GMP regulatory environment.
The successful candidate will support several aspects of validation, including design/author/review/approve/execute qualification/validation documentation and cycle development studies, execution/development of change controls, and technical input into quality notifications.
Key Responsibilities:
- Support the development and implementation of validation strategies and protocols.
- Conduct qualification and validation activities, including design, author, review, approve, and execute qualification/validation documentation and cycle development studies.
- Lead cross-functional teams to resolve technical issues and improve process efficiency.
- Develop and implement change control procedures to ensure compliance with cGMP regulations.
- Collaborate with production, maintenance, and quality teams to ensure seamless execution of cycle development and performance qualification activities.
- Provide technical input into quality notifications, including authoring, reviewing, and approving investigations.
- Perform root cause analysis of system failures and develop corrective actions to prevent reoccurrence.
- Serve as a subject matter expert on validation-related topics and represent the validation team at global technical forums.
Requirements:
- 5+ years of experience in a GMP validation role, with a strong background in pharmaceutical or biotechnology manufacturing.
- Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
- Demonstrable experience of leading technical-related projects.
- Knowledge of CTU equipment qualification, thermal mapping equipment, and thermal mapping skills.
- Exception / Deviation Management and Change Control.
- Ability to analyze and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
- Report, standards, policy writing skills required.
- Equipment and process validation.
- Sterile Fill-Finish processes and equipment.
- Proficiency in Microsoft Office and job-related computer applications required.
About Us
Claran Consultants Ltd is a leading consulting firm providing expert services in GMP validation, compliance, and process improvement. We are committed to delivering excellence and supporting our clients in achieving their goals.
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