*Compliance Coordinator, SCM
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We are looking for a skilled Compliance Coordinator who can be part of the daily, weekly, Monthly and annual Compliance and Training processes in Copenhagen.
About the Department
You will be a member of the Supply Chain Management department consisting of more than 60 colleagues with main responsibility for the areas: procurement, planning, warehousing and shipping. We support all AGC production and collaborate closely with key stakeholders and external suppliers through the entire supply chain. We are working in an international and customer oriented way to secure fast and reliable support to our customers.
The Job
We offer you an exciting job with many different areas of responsibility to work with many departments across the organization. As a Compliance Coordinator, your key objective is to ensure that we are in compliance at all times.
Your key responsibilities will be:
- Support daily operations job aids, training materials and in equipment and room qualification.
- Acting as SME during audit, follow up on audit responses.
- Ability to initiate Deviation/CAPA and Change Request as needed
- Take ownership for Quality KPI’s, Financial controls (J-SOX) controls.
- Preparation and maintenance of guidelines and procedures
- Taking part in local daily and annual GMP/GDP training.
- Ensuring a high level of Quality mindset and management.
The position demands strong ability to communicate verbally or in writing. Position requires regular cross department/function interaction and strong diplomatic skills. To be successful in this role you will take ownership securing timely closure of Deviation/CAPA/CR’s. Supply and support operations during audit and quality event. Securing timely audit response and timely and accurate reports to quality KPI’s.
Qualifications
- Relevant academic degree, Master, Bachelor’s, Pharmacist or equivalent experience from previous position and have an interest of working with quality and compliance in the pharmaceutical industry
- You will need very good communication skills and a positive mind-set in order to interact with both internal stakeholders and suppliers. You take pride in consistently delivering high quality work, on time and in a pro-active way. On top of that, you are able to prioritize your assignments in an ever-changing and dynamic environment, where you constantly estimate the consequences and risks in the decisions you make
- You have solid GMP/GDP and compliance background from pharmaceutical industry and a good understanding of ERP systems, preferably Microsoft D365 or Dynamics Axapta 2012.
- You have a structured way of working, strong analytical skills, winning and positive personality with a wish of making a difference every day in a hectic environment.
AGC Offers
AGC offers a dynamic working place with good opportunities of working with a varied array of manufacturing tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and we expect that you are able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team.
Application We continuously evaluate incoming applications and conduct interviews accordingly. Therefore, please submit your application and CV as soon as possible. When the right candidate is in place, then the ad will close. For further information regarding the position, please do not hesitate to contact Jovana Magdelinic Vulevic +45 2760 3134
Want to keep posted about our growth and to learn more about our company?
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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 21.9.2023, men kan have været deaktiveret og genaktiveret igen.
- Forretningsudvikler
- København
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