We are seeking a highly skilled Production Support Specialist to provide manufacturing support to process & product development projects, ensuring that product quality, regulatory & business requirements are met.
Key Responsibilities:
* Manufacturing support to process and product development projects.
* Responsible for reporting on project activities for manufacturing and operations.
* Support manufacturing onsite and at subcontractors/suppliers to ensure product quality, regulatory & business requirements are met.
* Track and report progress across projects by reviewing schedules and due dates, identifying risks and implementing contingency plans.
* Support resolution of NCR, NCM's and CAPAs ensuring effective solutions are implemented. Support Validation Activities including execution of protocols for equipment and process validations.
* Review and contribute to supplier process validation and risk management activities.
* Assess and approve process changes ensuring product impact is appropriately considered. Compile any necessary equipment/capital authorization requests supported with appropriate justifications and alternative options.
* Communicate effectively with all Internal & External Stakeholders.
* Collaborate with key suppliers and their production/ manufacturing teams to drive and support process/product improvements/developments.
Qualifications and Education Requirements:
* Relevant Level 8 qualification in Science/Engineering
* Experience in a Good Distribution Practices and Good Manufacturing Practices environment
* Good planning and organizational skills.
* Excellent communication, interpersonal and presentation skills.