Job Description
The following are the key responsibilities for both the positions:
- Lead the validation and qualification efforts for new equipment, facilities, and systems within the injectable plant, ensuring compliance with cGMP, FDA, and other relevant regulatory requirements.
- Develop and implement comprehensive validation master plans, schedules, and strategies for the injectable manufacturing processes.
- Oversee the preparation, review, and approval of validation protocols, reports, and other related documentation, ensuring accuracy and completeness.
- Manage and mentor the validation team, providing guidance and training to ensure the effective execution of validation activities.
- Collaborate with cross-functional departments, including production, quality assurance, engineering, and regulatory affairs, to ensure alignment and support for validation projects.
- Drive continuous improvement initiatives within the validation and qualification processes, incorporating industry best practices and technological advancements.
- Act as the primary point of contact for internal and external audits related to validation, addressing findings and implementing corrective actions as needed.
- Ensure that all validation activities are completed within the required timelines to support the plant's production and regulatory submission schedules.
Qualifications
M. Pharm (10 Years Minimum)
