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Summary Job Description
The technician holding this position carries out independently duties for the operation of equipment
according to established Standard Operating Procedures (SOPs) and the packaging of commercial
and clinical supply products in conformity with approved Master Production Batch Records and current
Good Manufacturing Practices (cGMP).
Accountabilities/responsible
Carries out independently the following packaging activities:
Strict application of gowning and sanitation procedures in force;
Inspection of product, after qualification, for the following:
o Hand inspection Lyophilised products;
o Hand inspection Liquid products;
o Hand inspection Media;
o Visomat IV inspection for Lyophilised and Liquid products.
Operating secondary packaging machines and equipment according to established
Standard Operating Procedures (SOPs).
o Semi-automatic inspection machine;
o Labelling machine (including printing and control systems);
o Carton coding machine.
Cleaning of secondary packaging machines and equipment;
Records accurate entries in Master Batch Records and Logs;
Supports activities for validation and calibration processes;
Initials employee:____________
Label en Pack Technician II
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JOB DESCRIPTION
Follows defined health, safety and environmental procedures;
Supports in manufacturing operations, when requested;
Assists in training of new employees on secondary packaging, when requested;
Participates as a member of a work group, shares information with others;
Contributes to workplace meetings and discussions;
Able to follow instructions and directions in a regulated environment.
Communication
Reports daily to the Supervisor Label and Pack about secondary packaging activities and
priorities, as well as improving efficiencies on the shop floor.
Participates in departmental meetings.
Job requirements
Technical education at a minimum of MBO level;
Demonstrate willingness to learn;
Produce a high level of accuracy;
Works within production timeframes & deadlines;
Verbal and written skills in the Dutch and English language;
Appropriate knowledge of cGMP standards and 1 year in a cGMP environment preferably in
the pharmaceutical industry;
Knowledge on low complexity tasks supporting the manufacturing operation;
Preferably Pharmaceutisch Vakman;
Confident user in Microsoft Word and Microsoft Excel.
Competencies
Action Oriented
Technical Learning
Listening
Interpersonal Savvy
Drive for Results
Version dated: June 2010
Employee :