Validation Specialist-East Durham,NY
Contract position-10 months
JOB PURPOSE :
The Validation Specialist is responsible for generation and execution of process and cleaning protocols and ensuring they are completed in a timely manner and to compliance standards.
Key Responsibilities:
• Plans, schedules, monitors, and executes all process and cleaning activities to ensure they are complete in a timely manner according to project timelines.
• Generation of process, cleaning, and control recipe validation protocols as defined in validation plan per local procedures.
Accountability:
• Write and execute process, cleaning, and control recipe protocols and summary reports for cleaning, packaging, and manufacturing processes as needed.
• Assume a leadership role in the development, planning, and implementation of process and cleaning protocols for cleaning, packaging, and manufacturing processes as needed.
• Coordinates resources needed to complete validation protocol execution.
• Provides support during execution of validation protocols on off-shifts as required.
COMPLEXITY
• Leads interactions with a wide and diverse stakeholder groups • Interactions with all functions within different departments • Strong ability to perform well under pressure in emergent situations • Sense of urgency • Ability to deal with complex documentation • Capable of influencing people outside validation to provide necessary input into validation process
KNOWLEDGE/EXPERIENCE :
• Experience in pharmaceutical industry
• Knowledgeable of all validation concepts, especially process and cleaning • Strong engineering background to understand process equipment is preferred • Working knowledge of cGMP regulations • Good technical writing skills • Must be well organised, able to prioritise work • Ability to work under pressure
Bala
Accounts Manager
SSAI Technologies LLC | Board: 908 450 9465| Fax: 908 842 0244 | www.ssaitech.com | Email: bala@ssaitech.com | bala.ssaitech@gmail.com
WBE/MBE certified for the State of NJ
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