Visual Inspection Specialist
We are seeking a skilled Visual Inspection Specialist to support our operations in line with all safety, regulatory and organizational requirements.
The successful candidate will have relevant experience in technical/operations/quality roles, preferably in pharmaceutical or healthcare organizations. A strong understanding of manufacturing processes, including biotechnology and sterilization, is also essential.
The role involves working as part of a team to develop and modify procedures, participate in process validations, review protocols for completeness and accuracy, and execute protocols in a timely manner.
A relevant third-level qualification in engineering, science or technical discipline is required, along with at least three years of combined experience in the field.
Responsibilities:
* Support Visual Inspection operations in line with safety, regulatory and organizational requirements.
* Develop and modify procedures as needed to support manufacturing operations.
* Participate in process, equipment, and facilities validations efforts and projects implementations.
* Review and approve process-related commissioning, qualification, and validation protocols for completeness and accuracy.
* Establish, lead, and optimize the process for certification of technicians for visual inspection.
* Establish and maintain the defect library.
* Establish and execute the process for the trending of Visual Inspection Defects.
* Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements.
* Provide Technical Input to guide the development of SOPs for Visual Inspection.
* Leadership of manufacturing and validation activities during project life cycle.
* Coordination with internal/external stakeholders for the evaluation of particles/defects.
* Support of technical transfers for future product introductions to the site.
* Investigate process exceptions or malfunction incidents affecting the process.
* Liaise with Internal/External Engineering Personnel and Internal/External Quality personnel as required.
* Support the Production Team in ensuring that manufacturing process is enabled and maintained to meet output and yield requirements.
Requirements:
* A relevant third-level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable).
* At least three (3) years of total combined experience in Technical/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization.
* At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
* Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.
* Experience in clean utilities is desirable.