Manager for QA Compliance department

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We save lives worldwide. Would you like to join us?

Here is an opportunity to take a position as a manager where your leadership skills and QA knowledge will make a difference to support our production of vaccines.

About your new role:

If you are passionate about people management and working with quality management, you thrive on responsibility and a wide range of contacts, then you may be our new Manager for QA Compliance in AJ Vaccines. In the job as Manager for QA Compliance, you will be responsible for managing the department and ensuring the correct level of Compliance in our GxP areas. QA Compliance is part of Quality Assurance (QA) with approx. 50 people distributed in four departments. QA Compliance consists of currently 9 people who maintain and develop our GMP quality system, procedures and instructions according to current legislation. The department's other tasks include: conducting internal audits; to take on the role of host in inspections by authorities and audits by our customers; to process customer complaints; to participate in GMP training across the organization as well as the overall responsibility for contact with the authorities. In addition, the department also has the overall responsibility for our suppliers and distributors, including preparing and negotiating quality agreements and performing supplier audits.

Your responsibilities:

The team is going through a development and scaling up right now which means we are adding even more specialists to the team. You will this way have the opportunity of being part of shaping your own team. When you enter the team then task coordination, prioritization, corporation, and teamwork will be an important part of your daily work. You will be responsible for the overall QM system including incorporating new guidelines and legislation, establishing of new QA procedures, planning, execution and follow-up on inspections and audits (internal and supplier), contact with authorities, QMR, GMP Training and QMS from external parties. You will experience ambitious goals to support the stabile delivery of vaccines to our customers.

Who are you?

We imagine that you have a relevant academic education as Cand.pharm., Cand.scient., Cand.polyt. or similar education. In addition, you have solid management experience - minimum 3-5 years, most probably in the pharmaceutical industry. In addition, we imagine that you have:
  • Very good collaboration and communication skills and a solid management experience
  • Broad experience with GMP, including requirements for sterile medicine
  • Knowledge of manufacturing and testing of biological pharmaceuticals
  • Solid knowlegde with aseptical medicine production
  • Solid experience with inspections and audits
  • You speak and write Danish and English
  • As a person you have the desire and will to take responsibility and make a difference. You master to have the overview for the tasks, projects and other promised deliveries for the team. You put an honor in that the tasks you and the team are providing is delivered in a high quality. You master to plan resources, so the team can also absorb a portion of unplanned tasks coming from the side together with the known tasks. Here you use your structure and ability to make a task overview visible to the team with clear priorities. You secure a consistent progress on the tasks for your team and yourself. You can remain calm in situations with high workload and secures a spirit in the team where people treat each other well.

    We offer

    An exciting and varied job in an international company with high professionalism and great commitment and with a great opportunity to shape the work tasks yourself. You will have a wide range of contacts both externally and internally with skilled colleagues in an environment where professional sparring is a natural part of everyday life and with good opportunities for development and insight on the professional and personal level. We have a relaxed tone with space for everyone, and we look forward to having you as our new colleague. We live in central Copenhagen close to the Metro Station Island Brygge and free parking on the Site Area.

    About AJ Vaccines

    AJ Vaccines is an international pharmaceutical company based on more than 100 years of experience. We are growing rapidly and are constantly taking new paths. We develop our production and invest in our facilities as we have a mission to develop innovative vaccines and diagnostic and therapeutic solutions of the highest quality worldwide. We are passionate about our work and we are proud of our products that prevent and treat serious diseases across generations - life for life.

    How to apply

    ISG Danmark is responsible for the recruiting process. To apply, send your application and cv asap to application.wadsholt@isg.com with ref.no. 86001 in the headline or click apply. Questions? Reach out to Partner Peter Wadsholt at ISG Danmark on peter.wadsholt@isg.com or phone +45 53 55 59 61. You can also apply through our ISG career portal.

    Visit isg.com/jobs/search - here you can find new job offers every day.

    ISG Denmark- www.isg.com/dk
    Rådhuspladsen 16, 1500 København V.
    Gammel Kongevej 1, 1610 København V.
    Virumgade 7 - 9, 2830 Virum
    Peter Wadsholt, M: +45 53 55 59 61
    @:application.wadsholt@isg.comAPPLY

    Skriv i din ansøgning, at du fandt jobbet på ofir.dk


    Manager for QA Compliance department

    We save lives worldwide. Would you like to join us?

    Here is an opportunity to take a position as a manager where your leadership skills and QA knowledge will make a difference to support our production of vaccines.

    About your new role:

    If you are passionate about people management and working with quality management, you thrive on responsibility and a wide range of contacts, then you may be our new Manager for QA Compliance in AJ Vaccines. In the job as Manager for QA Compliance, you will be responsible for managing the department and ensuring the correct level of Compliance in our GxP areas. QA Compliance is part of Quality Assurance (QA) with approx. 50 people distributed in four departments. QA Compliance consists of currently 9 people who maintain and develop our GMP quality system, procedures and instructions according to current legislation. The department's other tasks include: conducting internal audits; to take on the role of host in inspections by authorities and audits by our customers; to process customer complaints; to participate in GMP training across the organization as well as the overall responsibility for contact with the authorities. In addition, the department also has the overall responsibility for our suppliers and distributors, including preparing and negotiating quality agreements and performing supplier audits.

    Your responsibilities:

    The team is going through a development and scaling up right now which means we are adding even more specialists to the team. You will this way have the opportunity of being part of shaping your own team. When you enter the team then task coordination, prioritization, corporation, and teamwork will be an important part of your daily work. You will be responsible for the overall QM system including incorporating new guidelines and legislation, establishing of new QA procedures, planning, execution and follow-up on inspections and audits (internal and supplier), contact with authorities, QMR, GMP Training and QMS from external parties. You will experience ambitious goals to support the stabile delivery of vaccines to our customers.

    Who are you?

    We imagine that you have a relevant academic education as Cand.pharm., Cand.scient., Cand.polyt. or similar education. In addition, you have solid management experience - minimum 3-5 years, most probably in the pharmaceutical industry. In addition, we imagine that you have:
  • Very good collaboration and communication skills and a solid management experience
  • Broad experience with GMP, including requirements for sterile medicine
  • Knowledge of manufacturing and testing of biological pharmaceuticals
  • Solid knowlegde with aseptical medicine production
  • Solid experience with inspections and audits
  • You speak and write Danish and English
  • As a person you have the desire and will to take responsibility and make a difference. You master to have the overview for the tasks, projects and other promised deliveries for the team. You put an honor in that the tasks you and the team are providing is delivered in a high quality. You master to plan resources, so the team can also absorb a portion of unplanned tasks coming from the side together with the known tasks. Here you use your structure and ability to make a task overview visible to the team with clear priorities. You secure a consistent progress on the tasks for your team and yourself. You can remain calm in situations with high workload and secures a spirit in the team where people treat each other well.

    We offer

    An exciting and varied job in an international company with high professionalism and great commitment and with a great opportunity to shape the work tasks yourself. You will have a wide range of contacts both externally and internally with skilled colleagues in an environment where professional sparring is a natural part of everyday life and with good opportunities for development and insight on the professional and personal level. We have a relaxed tone with space for everyone, and we look forward to having you as our new colleague. We live in central Copenhagen close to the Metro Station Island Brygge and free parking on the Site Area.

    About AJ Vaccines

    AJ Vaccines is an international pharmaceutical company based on more than 100 years of experience. We are growing rapidly and are constantly taking new paths. We develop our production and invest in our facilities as we have a mission to develop innovative vaccines and diagnostic and therapeutic solutions of the highest quality worldwide. We are passionate about our work and we are proud of our products that prevent and treat serious diseases across generations - life for life.

    How to apply

    ISG Danmark is responsible for the recruiting process. To apply, send your application and cv asap to application.wadsholt@isg.com with ref.no. 86001 in the headline or click apply. Questions? Reach out to Partner Peter Wadsholt at ISG Danmark on peter.wadsholt@isg.com or phone +45 53 55 59 61. You can also apply through our ISG career portal.

    Visit isg.com/jobs/search - here you can find new job offers every day.

    ISG Denmark- www.isg.com/dk
    Rådhuspladsen 16, 1500 København V.
    Gammel Kongevej 1, 1610 København V.
    Virumgade 7 - 9, 2830 Virum
    Peter Wadsholt, M: +45 53 55 59 61
    @:application.wadsholt@isg.comAPPLY

    Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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