QUALIFIED PERSON – FULL TIME HYBRID POSITION – ONSITE 2/3 TIMES A WEEK
The Role:
The Qualified Person will be responsible for supporting Quality Operations Europe. The primary role will be to review and QP certify imported batches in preparation for release onto European markets and to carry out associated support activities. The QP will also be responsible to support the maintenance of the MIA under which the import and certification activities occur, participating in inspections, executing inspection follow up (CAPA) and supporting inspection readiness activities. The role will also involve oversight of the Quality Management System (QMS).
Daily Responsibilities:
Batch Review and Certification:
Ensure that every batch of medicinal product to which the Manufacturers/Importers Authorisation (MIA) relates has been manufactured and checked in compliance with:
- The requirements of Good Manufacturing Practice
- The provisions of the Marketing Authorisation (MA)
- The laws in force in the Member State where certification takes place.
Quality Management System (QMS):
- A quality management system is implemented and maintained.
- Any contract testing laboratory used for testing of third country imports is capable of carrying out the required analysis and that any such laboratory is approved by the competent authority.
- There are regular audits/visits to the site of manufacture by the QP and/or by persons of appropriate competence..
- In all cases, the QP should assess the significance of any deviations or out of specification results relating to the manufacturing and testing of a batch.
MIA:
- Be conversant with conditions attached to the MIA and ensure that conditions are observed in operations of the manufacturer.
- Ensure that the competent authority is informed in advance of any proposed changes which will affect the MIA.
- Ensure that there are formal procedures for the effective communication between the product licensing authorities and manufacturing departments in all regulatory matters.
- Be involved during regulatory and customer inspections of the MIA site.
MA Compliance:
- Ensure that the manufacturing and control procedures are not changed unless these have been approved by the relevant competent authority. Be aware of any amendments to the MA and ensure that these are implemented on the agreed date.
- Ensure that the support staff and facilities available within the company are adequate to meet the terms of any MA and for compliance with GMP.
Preferred Skill
- Proven ability to meet deadlines.
- Strong supervisory and leadership skills.
- Experience in partnering with key internal business stakeholders and will work cross functionally on continuous improvement activities to drive effective, compliant, and sustainable solutions.
- Extensive experience in understanding of the regulatory requirements governing pharmaceutical products in Europe.
Qualifications:
- Meets the education requirements for EU Qualified Person (QP).
- Minimum 10 years of Pharma experience and at least five years’ experience as a QP.
- Experience in biological medicines.