Pharmanovia is a specialty pharmaceutical company focused on the commercialization and marketing of niche pharmaceutical products and medical devices in specific therapeutic areas.
The main expertise lies in Sales & Marketing and Business Development. Pharmanovia has an entrepreneurial DNA. This has driven the success in acquiring, licensing and developing many medicines in numerous markets over the past 15 years.
Pharmanovia is offering a challenging and exciting job as Senior QA Specialist and QP. The tasks will primarily be to perform QA related GDP, GMP and GVP activities, like audit of the contract manufacturers and distributers.
Main role and responsibility
- Maintain GDP/GMP/GVP quality system.
- Writing and maintaining SOP.
- Internal GDP/GMP/GVP training of employees
- Review incoming customer complaints and prepare responses to internal/external customers
- Handling risk assessment, change controls, deviations and CAPA.
- Trend analyses for complaint and deviation
- Quality management reports
- Review quality and technical agreements
- Perform GDP and GMP audit, and GVP audit at distributers.
- Preform batch release as QP
- Function as RP
The Senior specialist/QP will report to the Head of Regulatory Affairs and QA.
- Sc. degree in Pharmacy or another relevant M.Sc. within science and with relevant experience.
- Experience QP
- Preferably 8-10 years of working experience within QA and as a QP
- Knowledge of Pharmacovigilance.
- Experience in handling PV information/contract/ADR to PV-consultant.
- Knowledge about GCP could be an advantage, but not a demand
- Experience with project coordination and analytical skills
- Excellent IT skills including good proficiency in Microsoft Office
- Excellent Danish and English communication skills (written and oral).
- Must be well-structured/-organized, detail oriented and capable of working independently
- Must have the ability to manage multiple priorities and meet scheduled milestones
- Must be a team player and be able to work in an international team on complex issues, coordinating efforts with externals partners.
- Pro-active with a positive and flexible mindset
- Be able to think out of the box, creative and willing to learn and adapt new things
For more information about Pharmanovia please www.pharmanovia.com
Interviews will be conducted currently, so please do not hesitate to send your application, and always feel welcome to contact SAM International for further details - Senior Consultant Peter Samuelsen - PSA@sam-int.com / +45 40580568
Please note that due to GDPR rules we do not accept applications/CV via e-mail.
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