GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs.
We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below: Pharmaceutical Inspection Operator Responsibilities To work as a team member to support biologics operation in pharma operations in line with all safety, regulatory and organizational requirements.
Visual Inspection Technician will be assigned to the daily production operations .
Documentation of all activities in line with cGMP requirements.
Perform final product visual inspection.
Perform product intermediary packaging, as applicable.
Perform in process testing methods.
Monitor Process Alarms.
Material receipt from warehouse, verifying all pertinent documentation.
Transfer of final material to warehouse inventory.
Ensure all manufacturing documentation is completed on a timely manner without errors, following cGMP's.
Diagnose and resolve events or exceptions of VI process.
Disposal of domestic, biomedical, and hazardous waste from their respective area as applicable, ensuring compliance with regulations following the procedures and policies of the plant, division, and the corporation.
Keep detailed records, manual or electronic, of the operations carried out during the work shift.
Active Participation in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment.
Adhering to all relevant policies relating to Quality & Safety.
Ensure successful external inspections, and Division and Corporate audits.
Active participant in the development of batch records and electronic batch records for the site.
Work with Engineering, Quality and other departments in the development and update of Standard Operating Procedures.
Requirements Leaving Certificate and 1 years' experience in GMP manufacturing 1 year plus of Knowledge of GMP and regulatory requirements relating to the pharma/biologics industry.
1 year in Batch processing operations in an FDA/ HPRA regulated industry is highly desirable.
Essential: Requires annual visual test certification for colour blindness and 20/20 vision.
A good knowledge of cGMP and regulatory requirements relating to the biologics/pharmaceutical industry is desirable.
Experience in handling of dangerous chemicals is highly desirable.
Good I.T.
skills are required.
Possessing previous Inspection experience in a Pharma/Biologics facility is a distinct advantage for operators assigned to VI.
Cognitive Skills Requires proven problem solving skills under the pressure.
The position requires detailed evaluation of a number of viable solutions to each problem.
Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders Requires total commitment to Quality and maintaining a high standard of work at all times.
Demonstrates the highest levels of integrity and a strong work ethic at all times Strong communication skills both verbal and written are required for the execution of this role.
Strong interpersonal skills are required.
Understands and supports the principles of Perfect Performance.
We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment.
If you are a motivated Inspection Operator seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.
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