GMP Support / Compliance Manager
This vacancy has now expired. Please see similar roles below...
A job vacancy for a GMP Support/Compliance Manager has arisen at a leading global pharmaceutical company specialising in the development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas. This is an exciting opportunity to bring Cleaning Validation and Compliance Specialist expertise to the role and partner it with a dynamic and well-established company.
Job Responsibilities:
- Managing cleaning verification activities as well as supporting and representing the GMP officer
- Preparing the relevant documentation (assessments, protocols and reports) for cleaning verifications related to the production of solid dosage forms in multipurpose facilities and equipment
- Supporting cleaning verification activities on shop floor.
- Regularly updating of the cleaning validation master documents.
- Representing and supporting the GMP officer in ensuring overall GMP compliance, including the handling of deviations and change controls.
- Preparing and supporting internal audits and HA inspections.
- Authoring and reviewing production and project related GMP documents (Qualification documents, trending reports, SOPs, Logbooks).
- Supporting and giving GMP training in collaboration with other team functions to ensure training compliance.
Skills and Requirements:
- Pharmacist, Chemist, Pharmaceutical Engineer or other equivalent natural science education.
- Languages: German and English in spoken and written (mandatory).
- Track record of working in GMP environment and having quality- or production-related responsibilities.
- Experience in the field of cleaning validation in drug product or drug substance manufacturing
- Microbiological Knowledge is a plus.
- Formal training in continuous improvement methodology such as LEAN/6-Sigma; Green or Black Belt certification is desirable.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kelechi Dyke at +44 203 854 0200 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-KD2
#Compliance/Quality
Related jobs
Highly Competitive Salary
Lexington, USA
Proclinical is seeking a dedicated Project Manager to lead IT projects within business applications and IT infrastructure. This is a contract position located in Lexington, MA.
Highly Competitive Salary
Indianapolis, USA
Proclinical is seeking a dedicated and innovative Electrical Engineer to join our Engineering Operations Team. This is a permanent position located in Indianapolis, IN.
Highly Competitive Salary
New Haven, USA
Proclinical is actively seeking an Upstream Associate Scientist. This is a contract position located in New Haven, CT.
Highly Competitive Salary
Boston, USA
Proclinical Staffing is seeking a Senior Director, of Antibody Bioconjugate Discovery to join an innovative biotech developing next generation neurogenetic medicines.
Highly Competitive Salary
Leeds, England
Proclinical is seeking a dedicated Clinical Statistical Programmer with a focus on Oncology. This is a remote permanent position.
€64000 - €98000 per annum + Highly Competitive Salary
Mainz (55131), Germany
Proclinical is seeking a dedicated and proactive Manager for Biomarker Operations. This is a permanent position located in Mainz, Germany.
Highly Competitive Salary
Leeds, England
Proclinical is actively seeking a Senior Regulatory Consultant. This is a remote contract position.
Highly Competitive Salary
Leeds, England
Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position.
Highly Competitive
Basel, Schweiz
Proclinical sucht einen Backend-Entwickler/DevOps für unsere offene eHealth-Datenplattform.
Highly Competitive
Koblenz, Germany
Proclinical ist auf der Suche nach einem engagierten und qualifizierten Techniker für Sauerstoffproduktionsanlagen.