Senior Operator Packaging

Prothya Biosolutions; Amsterdam; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Total shift allowance of 14.83%

8.33% end-of-year bonus

8.33% holiday allowance

Personal training budget of €2,100 every three years

Contribution to travel expenses

Pension plan

Dynamic and challenging working environment

Job summary

A leading pharmaceutical company in Amsterdam is seeking a Lead Talent Acquisition to manage production processes and train employees in a GMP environment. Ideal candidates should have a Bachelor's degree and over 5 years of relevant experience. The company offers full-time employment with a competitive salary, shift allowance, and training budget.

Qualifications

• Over 5 years experience in a similar function within a GMP controlled environment.
• Strong pharmaceutical packaging process experience.

Responsibilities

• Manage part of the production process.
• Train employees and ensure compliance with quality standards.
• Monitor quality and quality systems.
• Operationally manage a team of employees.

Skills

Detail-oriented

Team player

Fluent in Dutch

Fluent in English

Education

Bachelor education in a relevant discipline

Job description

Lead Talent Acquisition at Prothya Biosolutions

Performing pharmaceutical packaging activities under quality conditions for blood plasma and intermediate products manufactured, including a number of different in nature, mostly daily recurring production operations.

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.

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

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;
• Assess 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.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Production

Industries

Pharmaceutical Manufacturing