About The Job
Perform buffer/media preparation for all biopharmaceutical production areas of RM-BG and XPand C, and all related tasks ensuring successful production runs to achieve the company’s goals.
Reporting To
Buffer Preparation Section head
Department
Biotechnology Production
Benefits
Medical Insurance - Social Insurance - Life Insurance - Profit Share - Meal - Transportation
Responsibilities
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Strongly obey all GMP rules related to the field of employment.
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Operate production equipment necessary for buffer preparation processes in the production areas of RM-BG and XPand C
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perform buffer/media preparation in all biopharmaceutical production areas according to production plan
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organize the cleaning
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sanitation & sterilization of equipment and tools used for preparing buffers or media
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supervise the technicians during the production process.
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Follow up maintenance of production equipment as per defined plan.
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Receive and keep documents (SOPs
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validation protocol
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change control
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etc.)
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Issue new SOPs and revise approved SOPs according to revision plan according to instructions.
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Notify timely all incidents to supervisor and QA
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participate in investigation and assessment of incidents
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deviations and changes
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perform root cause analysis and contribute to SMART corrective and preventive actions for audit findings
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implement CAPA
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additional controls
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change control actions
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annual report actions and management review actions according to instructions.
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Participate in process and cleaning validation as per defined in relevant protocol
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participate in equipment internal calibration according to instructions; and calibrate if necessary.
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Issue materials and tools dispensing order needed for the production process and follow up relevant stocks.
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Support supplier qualification for raw materials and consumables used in production process.
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Contribute to quality risk management projects
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support continuous process improvements
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report and support assessing environmental hazard aspects and impacts
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report and support assessing health and safety risk assessment.
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Contribute to ramping up and establishing production in XPand C.
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Strongly cooperate with other departments/ sections (for instance USP
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DSP
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QA
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QC
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warehouse
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engineering) aiming at smooth and efficient production and process flow
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Perform any additional tasks as requested in the field of employment.
Requirements
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Experience: 0-3
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Self-organizing skills.
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Communication skills to all levels of staff.
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Analytical skills with attention to details.
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Flexibility according to the needs of the processes.
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Fluent in English Language.
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Computer literate.
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Ability to understand and follow written instructions.
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Ability to work under pressure
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