Quality Systems Compliance Lead
Good Manufacturing Practice (GMP)
Germany
Wuppertal, Germany
Posting date:
15 Jul 2022
46465
This vacancy has now expired. Please see similar roles below...
Proclinical are recruiting a Quality Systems Compliance Lead for a pharmaceutical establishment. This role is on a permanent basis and is located in Wuppertal. This client is focused on forming an open-access platform with the most wide-ranging abilities.Responsibilities:
- Direct the periodic management review and yearly process evaluation/CPV.
- Be a part of the site start-up which involves forming the company's quality system and affiliated guidance cascade across all functional areas.
- To assist all GMP/GDP actions, you will assist all fields of the business by collaborating with manufacturing.
- You will form QMS function which involves the affiliated framework and structure for management if quality linked documentation.
- Qualify CMO/CRO.
- Contribute to international QMS projects and guarantee international execution and delivery in line with regulatory and client expectations.
- Other duties may be assigned to this role.
Skills & Requirements:
- Ideal to have experience working in a bio-pharma or a pharma/science background, as well as CDMO experience.
- Familiarity with guiding a team across various QA functional areas, preferably within a start-up, maintaining phase.
- Acquaintance in a highly regulated setting, which involves FDA, EMA, and Chinese FDA (NMPA) regulations relating to API manufacturing.
- Know-how of EU guidelines internationally and legislative needs.
- Prior involvement as a Lead GMP Auditor.
- Assist in the scope of accountability and level of responsibility.
- Educated to a degree level in a biopharmaceutical science or any other similar field.
- Comparable qualification with demonstrated experience will be considered.
- Qualified as a qualified person as per the EU directive 2001/83/EC Behavioural Competencies
- Communication skills both verbally and in writing with the ability to work in a matrix setting.
- Leadership capabilities who works well in a team.
- Able to think analytically with the capacity to make decisions based on their risk level.
- Outcomes and solutions oriented.
- Capable of thinking strategically with the drive for business consistent development and client focus.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
LI-JV2
QACompliance
PrintRelated jobs
Scientist QC Raw MaterialsSalary
Highly Competitive
Location:
Visp, Schweiz
Proclinical is seeking a dedicated Scientist QC Raw Materials to join a team focused on quality control within the Primary Packaging and Raw Material sector.
Ashley Bennett
Apply
Sr QA Specialist
Salary
US$55 - US$63 per hour + Highly Competitive Salary
Location:
Cambridge, USA
Proclinical is seeking a Quality Assurance Specialist to join our team. In this role, you will focus on maintaining quality and regulatory standards within manufacturing processes.
Anderson Maldonado
Apply
Material Planning Analyst (Senior)
Salary
Highly Competitive Salary
Location:
Solothurn, Switzerland
Proclinical is seeking a dedicated Materials Planning Specialist to support manufacturing planning for clinical and commercial programs.
Ashley Bennett
Apply
Biomanufacturing Associate
Salary
Highly Competitive Salary
Location:
Philadelphia, USA
Proclinical is seeking a Manufacturing Associate to join our team in Philadelphia.
Mike Raletz
Apply
QA Project Leader for Drug Product
Salary
Highly Competitive
Location:
Visp, Switzerland
Proclinical is currently working alongside a contract manufacturing organisation to recruit for a QA Project Leader for Drug Product. This temporary contract position is based in Visp, Switzerland.
Olivier Worch
Apply
QA Associate
Salary
Highly Competitive
Location:
Bern, Switzerland
Proclinical sucht einen engagierten Qualitätssicherungsspezialisten für unser Team.
Emile De Beer
Apply
Welding Quality Inspector
Salary
Highly Competitive
Location:
Visp, Switzerland
Proclinical is currently working alongside a contract manufacturing organisation to recruit for a Welding Quality Inspector. This is a temporary contract position based in Visp, Switzerland.
Ashley Bennett
Apply
close
Search
close
Home
About us
Join us
Contact
Jobs
Upload CV
Proclinical Staffing
Proclinical Consulting
Proclinical Executive
Proclinical Engage
Job Opportunities
Our Services
Submit vacancy
Insights and Advice
Meet the Team
Login Header
Login
Register a new accountForgot your password?
frm: Please supply a valid email
Please supply a valid email
Reset
Please check your email inbox. If we were able to find an account using the email address you provided, we will have sent instructions to you on how to reset your password. If you have not received anything after an hour or so, it may mean you entered your email address incorrectly or do not have an account with us.
frm
Please check your email inbox. If we were able to find an account using the email address you provided, we will have sent instructions to you on how to reset your password. If you have not received anything after an hour or so, it may mean you entered your email address incorrectly or do not have an account with us.
mehr...
zur Vakanz
Weitere Jobs von Proclinical