QA Coordinator
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Hellerup
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a Copenhagen-based biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in Boston, and Marlborough (MA).
We are looking for an experienced QA Coordinator in our Quality Systems team.
The QA Coordinator collects, organizes, monitors and distributes information related to quality and process improvement functions, including but not limited to compliance to and documentation of quality management standards. Furthermore, the QA Coordinator participates proactively in the Quality System team to implement quality projects, follow up to obtain compliance, set standards for good recordkeeping, generate reports and using computer skills and communicate with suppliers and internal departments.
In Zealand QA we are a team of 12 and we act as Quality Partners for the GLP, GCP, GMP and IT area internally as well as quality oversight of our suppliers. The position is placed centrally at our headquarter in Søborg. The new QA Coordinator will be part of the Quality systems team. In QA we thrive on reaching results together and we are data driven and obtain compliance via dialogue.
Job Profile
Responsibilities include:
• Ensure tracking and timely follow up on quality related documentation hereunder deviations, change controls & audits
• Assist in the planning and follow up of the quality audit program
• Become super user of the Quality Module in our validated documentation system, covering change management, deviation and CAPA management
• Become the QA super user of Zealand’s EDMS system
• Ensure routine KPI reporting to management on relevant Quality topics
• Be an active part of records management and data governance in QA
• Support the Quality Management Review – drive selected processes, compile data and prepare for routine QMR including documentation and follow up
Candidate Profile
The successful candidate will have most or all of the below qualifications:
Experience
• 8+ years in experience with quality systems in the pharmaceutical/biotech industry
• Strong practical knowledge of all elements of a Pharmaceutical Quality System
• Superuser in a Quality computer system
• Implementing and tracking quality projects
Personal qualifications
• Pragmatic and yet with a compliant quality mindset
• High degree of structural skills and ability to transform them to practical solutions
• Strong communication skills verbally as well as in writing
• Energy and drive for team results, consistent high-performer
• Fluent in English (company language) and Danish
What we offer
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Our work environment is characterized by strong cross functional team-work, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.
At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.
We offer a combined compensation package which includes a base salary, pension, bonus, and an attractive employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities. To find out more about working at Zealand, visit www.zealandpharma.com.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company’s business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.
You are welcome to contact Beirholm Search tel. 29440080 for more information.
Interviews will be conducted on an ongoing basis, so please don’t hesitate to apply
Tags:job
Zealand Pharma A/S (Zealand) is a Copenhagen-based biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in Boston, and Marlborough (MA).
We are looking for an experienced QA Coordinator in our Quality Systems team.
The QA Coordinator collects, organizes, monitors and distributes information related to quality and process improvement functions, including but not limited to compliance to and documentation of quality management standards. Furthermore, the QA Coordinator participates proactively in the Quality System team to implement quality projects, follow up to obtain compliance, set standards for good recordkeeping, generate reports and using computer skills and communicate with suppliers and internal departments.
In Zealand QA we are a team of 12 and we act as Quality Partners for the GLP, GCP, GMP and IT area internally as well as quality oversight of our suppliers. The position is placed centrally at our headquarter in Søborg. The new QA Coordinator will be part of the Quality systems team. In QA we thrive on reaching results together and we are data driven and obtain compliance via dialogue.
Job Profile
Responsibilities include:
• Ensure tracking and timely follow up on quality related documentation hereunder deviations, change controls & audits
• Assist in the planning and follow up of the quality audit program
• Become super user of the Quality Module in our validated documentation system, covering change management, deviation and CAPA management
• Become the QA super user of Zealand’s EDMS system
• Ensure routine KPI reporting to management on relevant Quality topics
• Be an active part of records management and data governance in QA
• Support the Quality Management Review – drive selected processes, compile data and prepare for routine QMR including documentation and follow up
Candidate Profile
The successful candidate will have most or all of the below qualifications:
Experience
• 8+ years in experience with quality systems in the pharmaceutical/biotech industry
• Strong practical knowledge of all elements of a Pharmaceutical Quality System
• Superuser in a Quality computer system
• Implementing and tracking quality projects
Personal qualifications
• Pragmatic and yet with a compliant quality mindset
• High degree of structural skills and ability to transform them to practical solutions
• Strong communication skills verbally as well as in writing
• Energy and drive for team results, consistent high-performer
• Fluent in English (company language) and Danish
What we offer
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Our work environment is characterized by strong cross functional team-work, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.
At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.
We offer a combined compensation package which includes a base salary, pension, bonus, and an attractive employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities. To find out more about working at Zealand, visit www.zealandpharma.com.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company’s business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.
You are welcome to contact Beirholm Search tel. 29440080 for more information.
Interviews will be conducted on an ongoing basis, so please don’t hesitate to apply
Hanne Beirholm
Tags:job
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Hellerup.
Jobbet er oprettet på vores service den 3.6.2022, 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.
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