Manager Production - Packaging

GMP roles and responsibilities

Result areas

• Managing employees in the department.
• Implementing department policy according to quality requirements.
• Contributing to the (unit) policy.
• Taking care of production.
• Performing management and quality assurance.
• Carrying out all other work within the scope of the job.

Managing employees of the unit

• Ensures the organisation of activities and work within the unit. Directs and reviews theresults of employees.
• Ensures adequate staffing.
• Executes personnel policy within the department.
• As chairman, conducts periodic work consultations with the supervisors and employees ofthe unit and addresses them on results.
• Supervises and ensures the development and expertise of employees.
• Supervises working according to working conditions guidelines and quality guidelinesapplicable to the unit.

Result to be achieved

• Production Manager qualitatively and quantitatively adequate staffing; effective career and training policy; work in accordance with working conditions guidelines; motivated employees, low absenteeism, active knowledge exchange.
• Implementing departmental policies according to quality requirements
• Determines the production capacity and required investments in installations and infrastructure within the department, draws up a budget (formation, training and investment budget), manages the budget
• Translates the long-term operations policy formulated at unit level into the policy for the department.
• Organises departmental processes in line with lean principles and ensures that resources and systems support the processes.
• Aligns own department policy with the other managers within Prothya and ensures uniformity between the departments.
• Reports on developments to the Head of Production.
• Makes proposals for process improvement based on developments in the field and experiences with troubleshooting and unit policy, among other things. Takes related process lines into account.
• Contributes to optimal (policy) coordination, cooperation and information exchange within own unit and between units.
• Taking care of production.
• Is responsible for the realisation of qualitative (FDA, GMP) and quantitative production standards by the department, signals deviations and takes corrective measures.
• Is responsible for production at the lowest possible cost price, with minimal rejects, within set budgets.
• Monitors progress, safety and quality and (re)prioritises production activities if necessary.
• Is responsible for, ensures (as owner) and supervises the implementation of new techniques and equipment.
• Chairs multidisciplinary (QC, QA, Prod) committees if needed.
• Maintains internal and external contacts, including in connection with planning and capacity forecasting.
• Production process proceeds in accordance with production objectives and standards, GMP guidelines and regulations.
• Together with fellow production managers, is responsible for the design, implementation, monitoring and maintenance of the quality management system within production as described in GMP guidelines.
• Ensures a culture of continuous improvement in accordance with lean principles.
• Supervises compliance with quality requirements and regulations during production activities and adequate and correct registration of data, irregularities and deviations.
• Takes care of and, if necessary, participates in the handling of CAPAs and change control processes and the execution of routine validations and investigations into events within the department.
• Analyses the process flow and documents production actions.
• Manages production facilities, raw materials, installations and auxiliary materials.

Your profile

• University-level working and thinking skills in chemistry, pharmacy, biology, or process technology, supplemented by several years of work experience.
• > 5 years of managerial experience.
• Strong knowledge and proficiency in coaching, leadership and management techniques.
• Strong knowledge of change management.
• Strong knowledge of procedures and guidelines regarding laboratory analyses, quality controls, and/or scaling up production processes.
• Strong knowledge of GMP, Lean/OPEX, and quality systems.
• Strong knowledge of biological purification processes, technology, software and quality care and their correlation with the own field of expertise.  
• Excellent knowledge of the Dutch & English language both verbal & written. 

Our Offer

• Full-time employment (40h).
• Salary between € 6.215,77 and € 8.935,13 gross per month based on full-time employment.
• 8.33% end-of-year payment (13th month) and 8.33% holiday allowance.
• 30 holiday days.
• 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.