quality manager / qualified person dkma
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Taastrup
On behalf of our customer FREJA, Randstad is looking for a Quality Manager, who will be responsible for FREJAs quality management systems and who will act as FREJAs Qualified Person and responsible towards DKMA, Danish Medicines Agency. In this role, you will become part of an international growth company with headquarters in Denmark and will get the opportunity to influence and form FREJAs quality organization in general and in the pharmaceutical area in particular.
In this role, you will be reporting directly to FREJAs QES Manager and be key within executing the company’s quality journey. You will ensure that quality management systems are established, maintained and continuously improved in compliance with EU/DK GDP/GMP legislation and guidelines, and you will also act as the QP (Qualified Person), who holds responsibility towards the Danish Medicines Agency’s (DKMA).
In the QM role at FREJA you will ensure a high level of performance within the company’s quality work through the implementation and application of an efficient and effective QMS across the scope of FREJAs business. Furthermore, you will be key in ensuring that procedures are documented and implemented in all relevant aspects of FREJAs procedures.
As quality manager, you will work closely with all areas of the organization to drive quality improvement projects.
Your primary responsibilities and work tasks will be to:
- Head authority controls and participate in customer audits
- Responsible, internal and external audits
- Approve and assist in quality related change-control cases
- Perform training and education of staff within Quality, GMP/GDP guidelines
- Ensure that documentation, procedures and processes are maintained in compliance with industry and regulatory standards
- Act as Qualified Person, QP according to GMP authorization from DKMA, including API registration and storage
- Responsible for qualification/validation of GMP related equipment
- Responsible for evaluation and trending of GMP deviations and CA/PA’s
- Responsible for handling of product recalls on GMP products, according to mother client instructions
- Responsible for change control cases within GMP
You have experience with heading quality work, including lead auditor experience, in a similar role with a comparable company for a minimum of 3-5 years. You will also hold experience from creating quality management road maps and ensuring a future-proof eQMS across divisions and countries, covering not only the pharmaceutical area but also cargo in general. Your quality management skills are covering not only extensive know-how on GDP/GMP guidelines and QM in general but also a broad knowledge of ISO9001.
In order to cover the entrusted role as QP you will hold a Master of Science in Pharmacy or a similar university certificate of minimum 4 years’ duration.
In case, you do not hold such certificate, but at pharmacy technician certificate, we might consider adjusting the role for you to act as a RP/QA Manager only.
You have a process oriented mindset and excellent verbal and written communication skills. You are fluent in English and you enjoy documenting and coordinating activities. You hold the ability to interact professionally with a diverse group of stakeholders in a matrix environment. You have a high level of integrity and reliability, and know how to balance this with a high level of ambition and performance orientation. You are a coordinator and doer who works in a pragmatic and hands-on way.
On a personal level, we look for traits like:
- High level of integrity and accountability
- Initiative: recognizing and acting on opportunities
- Optimistic and open to change
- A self-starter rather than reactive, taking ownership
- Good listener, honest, open and able to interact with others in a positive way
- Persuasive and a strong negotiator – yet aiming to reach target by joint effort
- Strong networker: creates strong networks both internally and externally
- A natural trainer, thriving from teaching others how to succeed in quality work
- High Stress tolerance and resilient: Works effectively also after a setback
- A can-do and will-do attitude
Randstad is responsible for the recruitment process. If you have any questions regarding this position, please contact Head of Transition, MSc. Organizational Psychology, Malene Gude at email [email protected] or phone: +45 25 97 42 33. All applications will be treated in strict confidence and will be handled on an ongoing basis. The application must be in English.
At Randstad, we support people and organizations in realizing their true potential. We do this by combining the power of today’s technology with our passion for people. We call it Human Forward.
Randstad DK is part of the international Randstad Group, which is the global leader in HR services. With more than 4,700 offices in 38 countries, we are providing work to more than 650,000 people every day.
In Denmark, we are among the leading temp, recruitment and outplacement agencies with branches in Copenhagen, Aarhus, Aalborg and Kolding. A position we have achieved due to our expertise in matching qualified candidates with the right job opportunities.
About the position
In this role, you will be reporting directly to FREJAs QES Manager and be key within executing the company’s quality journey. You will ensure that quality management systems are established, maintained and continuously improved in compliance with EU/DK GDP/GMP legislation and guidelines, and you will also act as the QP (Qualified Person), who holds responsibility towards the Danish Medicines Agency’s (DKMA).
In the QM role at FREJA you will ensure a high level of performance within the company’s quality work through the implementation and application of an efficient and effective QMS across the scope of FREJAs business. Furthermore, you will be key in ensuring that procedures are documented and implemented in all relevant aspects of FREJAs procedures.
As quality manager, you will work closely with all areas of the organization to drive quality improvement projects.
Your primary responsibilities and work tasks will be to:
- Head authority controls and participate in customer audits
- Responsible, internal and external audits
- Approve and assist in quality related change-control cases
- Perform training and education of staff within Quality, GMP/GDP guidelines
- Ensure that documentation, procedures and processes are maintained in compliance with industry and regulatory standards
- Act as Qualified Person, QP according to GMP authorization from DKMA, including API registration and storage
- Responsible for qualification/validation of GMP related equipment
- Responsible for evaluation and trending of GMP deviations and CA/PA’s
- Responsible for handling of product recalls on GMP products, according to mother client instructions
- Responsible for change control cases within GMP
Your profile
You have experience with heading quality work, including lead auditor experience, in a similar role with a comparable company for a minimum of 3-5 years. You will also hold experience from creating quality management road maps and ensuring a future-proof eQMS across divisions and countries, covering not only the pharmaceutical area but also cargo in general. Your quality management skills are covering not only extensive know-how on GDP/GMP guidelines and QM in general but also a broad knowledge of ISO9001.
In order to cover the entrusted role as QP you will hold a Master of Science in Pharmacy or a similar university certificate of minimum 4 years’ duration.
In case, you do not hold such certificate, but at pharmacy technician certificate, we might consider adjusting the role for you to act as a RP/QA Manager only.
You have a process oriented mindset and excellent verbal and written communication skills. You are fluent in English and you enjoy documenting and coordinating activities. You hold the ability to interact professionally with a diverse group of stakeholders in a matrix environment. You have a high level of integrity and reliability, and know how to balance this with a high level of ambition and performance orientation. You are a coordinator and doer who works in a pragmatic and hands-on way.
On a personal level, we look for traits like:
- High level of integrity and accountability
- Initiative: recognizing and acting on opportunities
- Optimistic and open to change
- A self-starter rather than reactive, taking ownership
- Good listener, honest, open and able to interact with others in a positive way
- Persuasive and a strong negotiator – yet aiming to reach target by joint effort
- Strong networker: creates strong networks both internally and externally
- A natural trainer, thriving from teaching others how to succeed in quality work
- High Stress tolerance and resilient: Works effectively also after a setback
- A can-do and will-do attitude
Application and Contact Info
Randstad is responsible for the recruitment process. If you have any questions regarding this position, please contact Head of Transition, MSc. Organizational Psychology, Malene Gude at email [email protected] or phone: +45 25 97 42 33. All applications will be treated in strict confidence and will be handled on an ongoing basis. The application must be in English.
About Randstad
At Randstad, we support people and organizations in realizing their true potential. We do this by combining the power of today’s technology with our passion for people. We call it Human Forward.
Randstad DK is part of the international Randstad Group, which is the global leader in HR services. With more than 4,700 offices in 38 countries, we are providing work to more than 650,000 people every day.
In Denmark, we are among the leading temp, recruitment and outplacement agencies with branches in Copenhagen, Aarhus, Aalborg and Kolding. A position we have achieved due to our expertise in matching qualified candidates with the right job opportunities.
Information og data
Denne ledige stilling har jobtypen "Kvalitetskoordinator", og befinder sig i kategorien "Kontor, handel og service".
Arbejdsstedet er beliggende i Taastrup.
Jobbet er oprettet på vores service den 14.6.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Kvalitetskoordinator
- Taastrup
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