The primary focus of this role is to coordinate equipment installation, develop IQ/OQ/PQ protocols, and execute these protocols in accordance with cGMP requirements.
Key Responsibilities:
* Validation activities encompass a range of tasks, including facilities, utilities, validation life cycle, execution, technical documentation, process analysis, risk assessment, and others.
* Develop validation documents, execute IQ/OQ and PQ for equipment, systems, and utilities, and create reports on completed validation activities.
* Identify opportunities for improving the validation program approach and apply lessons learned.
* Stay informed about industry regulatory changes affecting equipment/facility validation.
* Perform assigned Quality Systems activities, including document management, change control, non-conformities, and CAPAs. Write or revise procedures relevant to Engineering activities.
* Support the Engineering group in developing the validation, requalification, and maintenance program.
* Perform additional duties as required.
Requirements:
* Bachelor's Degree in a Science or Technical field
* 3-5 years of experience in the pharmaceutical industry