Validation Specialist
2 days ago
Strides Pharma Inc is seeking a skilled Validation Specialist to join our Engineering Department. As a pivotal member of the team, you will operate both independently and collaboratively to author and execute IQ/OQ/PQ protocols, engineering studies, and facility qualifications.
Key Responsibilities:
- Ensure adherence to manufacturing specifications, Good Manufacturing Practices (GMP), and national standards.
- Author change controls, SOPs, and protocols.
- Generate and execute validation protocols, and summarize studies to ensure compliance with manufacturer and SPI specifications, with current Good Manufacturing Practices, and national standards.
- Responsible for confirming all communicated validation plans to applicable management.
- Provide technical assistance in the form of rationales or validation studies.
- Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches, and a strong understanding of processes and equipment.
- Troubleshoot and resolve issues as needed.
Project Management:
- Manage multiple projects with competing deadlines.
- Manage external resources to complete tasks outside SPI's capabilities.
- Manage approvers of documents and procedures and ensure timely closure of tasks.
- Manage project-related Change Requests from initiation through closure, including presentation to Change Control Committee.
- Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.
- Source and procure equipment, supplies, and other materials as needed.
- Develop and maintain cross-functional relationships.
Requirements:
- Bachelor of Science in Engineering or related field preferred.
- Experience in pharmaceutical, medical device, or biotechnology industries, particularly in validation, QA, or R&D roles.
Knowledge and Skills:
- Proficiency in FDA regulations, GMP/GLP/GCP, and Lean Manufacturing principles.
- In-depth understanding of pharmaceutical plant operations.
Physical Requirements:
- Regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
- Climb ladders and work in high, precarious places up to elevations of 75 feet.
- Regularly exposed to work near moving mechanical parts.
- Exposed to wet or humid conditions.
- Exposed to outdoor weather conditions.
- Regularly exposed to high noise environments.
- Exposed to extremely dusty environments.
- Exposed to chemicals used in the manufacturing process.
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