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GMP Support/Compliance Manager posted by ProClinical

6 days left to apply
Full Time
Cambridge

Job Description

GMP Support / Compliance Manager

Salary: £0.00 - £60.00 per hour
1. Job type: Permanent
2. Discipline: Good Manufacturing Practice (GMP)
3. Location: Switzerland

Basel
Posting date: 21 May 2019
Reference: QA.KD.23477_1558455991
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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 +Apply Now >> 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.

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#Compliance/Quality
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