Senior Operator Packaging Amsterdam • Prothya Biosolutions

GMP roles and responsibilities:

Managing part of the production process:

• Keeps knowledge up-to-date regarding the relevant part of the production process;
• Manages the control methodology and equipment associated with the relevant part of the production process;
• Advises the supervisor on possible modifications in and improvements of the process in the relevant part of the production;
• Does the "troubleshooting" for problems and consults with third parties about them;
• Establishes and leads projects in modifications and improvements after approval of the project plan;
• Reports project outcomes to supervisor;
• Performs administration and correspondence required for the production process.

Deliverable: Up-to-date knowledge of the relevant part of the production process, knowledge shared with employees; well-functioning production process and equipment

Performing production operations:

• Performs production operations according to SOPs and regulations;
• Performs arithmetic operations for the purpose of dilutions, among other things;
• Provides preparations for production process, cleans used equipment and materials after completion;
• Accounts for the performance of all work in logs and protocols;
• Identifies, records and reports deviations in prescribed operating procedure to supervisor;
• Administers raw and auxiliary materials in the information system and performs administrative processing of rejected materials;
• Performs minor (technical) maintenance on equipment, fixes malfunctions of a simple nature, reports malfunctions to the supervisor, has contact with internal or external experts/technicians when necessary and supervises them in handling malfunctions;
• Maintains inventory and ensures timely replenishment.

Training employees and ensuring compliance with quality standards:

• Ensures employees are adequately trained and inducted and coordinates employee requalification;
• Instructs employees on modified and new regulations and supervises their introduction;
• Ensures correctly and uniformly completed logbooks, batch files, etc. and addresses employees accordingly.
• Ensures that preparation is done only using authorized protocols and regulations and that deviations from authorized regulations/protocols are properly documented;
• Ensures that routine rehabilitation planning is performed and submits the results to the Head for authorization.

Result to be achieved: Employees instructed and trained such that they are able to perform their work independently in accordance with applicable procedures

Monitoring quality and quality systems:

• Writes validation and calibration protocols and quality documents;
• Performs checks on products, processes and (auxiliary) materials, including by sampling and inspection;
• Delivers samples for inspection at the designated location;
• Initiates and performs work on behalf of validation and calibration activities for own and other departments. Records the results of quality controls in the information system and writes reports;
• Adjusts regulations/protocols in response to audit findings; makes suggestions to keep existing regulations and protocols current and improved;
• Monitors water for injection (WFI) and work areas to be used;
• Identifies and processes discrepancies and Alertboard issues;
• Resolves internal complaints;
• Implements quality systems on the shop floor in coordination with the Head and QA;
• Participates in the preparation and implementation of new processes.

Result to be achieved: Monitored quality and quality systems such that preparations could be carried out in accordance with applicable guidelines and worked on continuous quality improvement

Operationally managing a team of employees:

• Sets work schedule for the team and coordinates work;
• Conducts work meetings with, motivates and coaches the team;
• Assesses the quality of work and, if necessary, addresses employees accordingly;
• Provides data to supervisor regarding employee performance;
• Reports to supervisor.

Deliverable: work organized in such a way that the team of employees is motivated and enthusiastic; work according to schedule and quality

Your profile:

• Bachelor eduation in a relevant discipline or equivalent level gained through experience
• >5 years experience in a similar function within a GMP controlled environment
• Strong pharmaceutical packaging process experience
• Detail-oriented, structured, proactive, and a strong team player
• Fluent in Dutch and English
• Willing to work in 2 shifts (morning/ evening)

What we offer:

• Full-time employment (40h) with a competitive salary.
• Total shift allowance of 14,83%.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.