Job Description
The Quality Assurance Manager (QM) will have the responsibility to lead the Quality Assurance activities at The J. Molner Company. The QM will be responsible for developing the quality infrastructure and related plans. The QM will monitor the quality-related activities and investigate any deviations from GMP guidelines. The QM will also monitor and approve the change management process and approve any planned CAPA actions. The QM is responsible for ensuring that The J. Molner Company employees are trained in their required procedures and are knowledgeable of GMP principles.
The Quality Assurance Manager will also define, monitor, and report on established KPI’s and relevant metrics to determine the efficiency and timeliness of all quality activities.
Essential Responsibilities:
- Responsible for ensuring that Standard Operating Procedures are up to date and follow GMP guidelines
- Responsible for ensuring that processes are performed in accordance with Quality Risk Management (QRM) processes.
- Responsible for ensuring compliance with local and international regulations, document and track regulatory commitments.
- Ensure that necessary training of employees is carried out, including regular training in GMP principles.
- Maintain the change control and CAPA activities. Review and approve the changes and CAPA forms submitted through the change control procedure.
- Responsible for ensuring that the deviation and out-of-specification/out-of-trend investigations are carried out.
- Review and approve investigation reports.
- Establish and maintain a quality metrics system for tracking and trending GMP activities.
- Control and archive approved documents.
- Review and approve validation protocols and reports.
- Ensure that regular self-inspections are carried out.
- Responsible for hosting regulatory inspections and third-party audits.
- Advise senior management on Quality related affairs.
Requirements
Qualifications:
- BS or higher degree in a technical discipline (e.g. chemistry, biology, engineering)
- A minimum of 2 years of quality assurance or regulatory compliance experience in pharmaceutical or other relevant industries.
- Understanding of EU and FDA regulatory systems and requirements.
- Excellent written and oral communications, project management, and team leadership experience from pharmaceutical or other fields.
Company offers
The J.Molner Company welcomes you with:
- Modern and fully equipped laboratory
- Health/sports compensation
- Annual holiday of 28 days + winter break between Christmas and New Year
- Team events
- Annually five days of 100% paid health leave if needed
- On-boarding and training program
