Working at Sirius Pharma Consulting

Sirius has world-wide pharmaceutical customers that need Sirius to be their EU/EEA batch release site. You will be part of a QA team that offers the role as Qualified Person and batch release for medicines either manufactured in EEA or imported from 3. Countries.

Responsibilities

• batch release of non-sterile solid dosage forms
• to be named on a Manufacturing Importation Authorisation (MIA) as a Qualified Person (QP) issued by the Malta Medicines Authority
• handling euphoriants/narcotics, including import and export licenses
• qualification of suppliers and transport companies
• technical agreements
• audits and authority inspections
• preparing PQRs
• complaints and market withdrawals, deviations, change requests and CAPAs
• maintain the company QMS
• you will also provide customers with QA support which can include assistance with qualification and validation, root cause investigations, deviations, change requests and CAPAs etc.

Qualifications

We expect you to be pharmacist by education (M.Sc. pharm). We expect you to have at least 2 years of experience in QA preferentially with batch release, and you need to document eligibility for QP status as defined by the Guidelines for submission of QP status applications published by Malta Medicines Authority.

Preferentially you have experience with both non-sterile solid dosage forms and sterile products (aseptically prepared and or terminally sterilized). Experience with non-sterile solid dosage forms is a must.

Experience within qualification and validation of pharmaceutical equipments is an advantage but not required.

You must have a permanent address on Malta.

Excellent verbal and written communication skills.

Contact information

If you want to learn more about the position or want to apply for the job, please contact:

Elise Hellesø Rinvar, Managing Director, Sirius Pharma Consulting Ltd. elise@siriuspharmaconsulting.com; mobile: +45 22 36 79 53