We’re looking for a highly experienced QA and project manager working within a GxP regulated environment.
Reporting to the Head of QA, you will be joining a team of experienced consultants who work with pharmaceutical companies in Denmark and Europe.
You will take on a number of roles and work closely with all our diverse, multinational staff:
Data Protection Officer
- Review internal IT platform deliverable compliance.
- Support internal IT projects and perform QA activities in accordance with relevant internal IT requirements and plans
- Review and provide feedback on relevant contracts with customers, including where relevant the RFI/RFP process, to ensure that the quality aspects of the documents reflect the current QMS
- Participate in vendor selection and ongoing vendor assessment as the QA representative
- Perform review of incident management
- Plan, perform and report internal audits in accordance with the plan for internal audits
- Ensure that the list of external requirements is updated when relevant
- Monitor the compliance with GDPR of services provided, serve as the main contact with relevant authorities, inform and advise S-cubed employees about the regulations regarding GDPR
- Handle deviations and CAPAs in SCalate and ensure follow-up, trending and reporting
- Plan and follow-up on QMS training, including e.g. maintenance of the training matrix for employees and relevant contractors, and filing of training documentation
- Plan and coordinate new or updates to QMS documents in accordance with the QMS CRs, relevant plans and business needs, and support SOP authors with drafting of QMS documents
- Release new QMS documents (SOPs, forms, templates) in accordance with the relevant release checklist
- Maintain all relevant lists, overviews and plans in accordance with SOP requirements
- Responsible for archiving of GxP paper records, including e.g., Visitor logs
- Responsible for ensuring that the digitisation of paper records is performed in accordance with the SOP requirements
- Maintain confidentiality of customer information and data
- Maintain knowledge level through appropriate training
- Stay informed about developments in GCP and Quality requirements in the pharmaceutical industry
- Provide advice and assistance to colleagues within S-cubed
- Supervise and mentor colleagues within S-cubed
- Maintain positive working relationships with colleagues at all times
Your Key Qualities and Qualifications
- Minimum 5 years of experience as a project manager for GxP compliant projects, including responsibility for quality assurance and representing the projects during audits
- Highly structured and quality conscious
- Ability to gain and maintain the overview of the tasks in hand
- Knowledge of GxP and QA requirements in the pharmaceutical industry and the medical device industry
- Responsive to client needs and focused on client satisfaction
- Excellent written and oral communications skills; must be articulate in explanations and communicate in a clear, positive fashion with clients, management and staff at all times
- Must read, write, and speak fluent English
- Dedication to quality and reliability in all work tasks
- Functions independently with little or no supervision
- A genuine commitment to team work on project teams and among regional staff
- Self-motivated, demonstrates an eagerness to grow professionally, and commitment to self-development
Due to the current pandemic, we are working from home. You must be able to stand on your own two feet and quickly adapt to working remotely but you will still have plenty of support.
NB. Once the current restrictions are lifted, there may be some travel involved in the position, as some projects may be at the client’s office and you may have to travel to another location.
We are a dynamic company with offices in the UK and Denmark (this role is based in Copenhagen). We have an informal working environment, and you will be part of our team based in our beautiful offices at Nordhavn. We have a strong culture based on our core values of: Integrity, Openness, Flexibility and Fun. We strive to ensure that you will feel part of our team and as such we offer flexible working for your personal situation and to ensure you have a good work life balance.
ARE YOU INTERESTED?
We will interview candidates on a rolling basis and this position will remain open until we find the right person.
If you want to find out more, please contact Kenneth Lindskov firstname.lastname@example.org.
Send us your CV
If you have a flexible and creative approach and have excellent communication skills (including the ability to speak and write English fluently), we would like to hear from you.
For unsolicited applications, we encourage you to upload and send you CV via the form. Your application will automatically be transferred to our CV database and will be saved for a maximum of six months.