Qualified Person - Semi Remote
- Employer
- Barrington James
- Location
- Frankfurt am Main, Hessen
- Salary
- Competitive
- Start date
- 18 Nov 2021
- Closing date
- 18 Dec 2021
View more
- Discipline
- Quality, Qualified Person
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Senior Management
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Job Details
Key Responsibilities:
- Maintaining a batch register.
- IMP import: Verify/evaluate import documentation and perform audits to proof that the drug has been manufactured and tested acc. to GMP.
- Prove that the drug has been manufactured, stored, labelled and tested acc. to EU GMP and acc. to the requirements of the German Drug Law.
- Perform GMP audits .
- Contribute to proper coordination of customer audits and inspections from regulatory authorities.
- Perform Vendor / supplier qualification incl. auditing
- Review Batch Packaging Records
- Issue, control and follow-up on complaints, deviations, CAPA, and change control.
- Annual self-inspection of Sites: support, conduct, participation and reporting to executive management.
- Maintenance of Site Master File.
- Support validation & qualification activities and processes in accordance with applicable legislation.
- Inform team and management on updates on regulatory requirements.
- Take part in the overall improvements of internal processes and systems.
- Perform training of Staff on GMP/GDP requirements and on the optimal use of the EU quality management system.
- Support a timely and effective communication and escalation process exists to raise quality issues of Executive committee.
- Contribute to establishment and achievement of required quality controls to maintain the quality of products and services provided by.
- Take part that Quality Control is performed accurately and efficiently in compliance with current legislation. Work with quality controls to guarantee the quality of finished products IMP (e.g. checks on incoming products being conditioned and finished products, specifications, sampling, reference sample).
- Contribute to the Quality Report for the Quality Management Review, where applicable.
- Training of Pharmacist´s applicants’ internship (Germany).
Experience:
- QP release Experiences with clinical trials and IMP is preferable but commercial QP release experience is acceptable. Experienced in GMP, GDP, and GCP requirements.
- Experience in management and line management role (minimal 4 years).
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
Company info
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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