Job Opportunity
About the Role:
We are seeking a highly skilled Manufacturing Operations Specialist to join our team. As a key member of our operations group, you will be responsible for ensuring the smooth execution of daily production operations.
Main Responsibilities:
* Perform thorough visual inspections and documentation of manufacturing activities.
* Maintain accurate and up-to-date records of operations carried out during each work shift.
* Participate in Factory Acceptance testing, Site Acceptance Testing, and commissioning and qualification of equipment.
* Ensure adherence to all relevant policies and procedures relating to Quality and Safety.
* Support the development of batch records and electronic batch records for the site.
Requirements:
* A minimum of 1 year's experience in GMP manufacturing is required.
* Strong knowledge of GMP and regulatory requirements is essential.
* Batch processing experience in an FDA/HPRA regulated industry is highly desirable.
* Annual visual test certification for color blindness and 20/20 vision is a requirement.
* Excellent IT skills are necessary.
* Prior inspection experience in a Pharma/Biologics facility is a distinct advantage.