Beschreibung
Documentation Specialist - QA/Drug/ RA/english /GMPProject:
For our customer a big pharmaceutical company based in Basel we are looking for a Documentation Specialist
Background:
GMP documentation Management belong Global Supply Chain & Affiliate Quality acting as SPOC (Single point of Contact) for Global Quality in the Regulatory Submissions, Renewal, Site Registration, launches, etc.
The GMP Documentation specialist will manage and ensure GMP documents are dispatched on time in full to the countries around the world to complete international submissions prior to dispatch to Health Authorities.
Tasks & Responsibilities:
* Assess and manage requests from internal and external stakeholders to obtain GMP documentation for international submissions to Health Authorities or for external customers (e.g. Line extension, NDA/BLA, New indication, Post Approval, Renewal, Site Registration, Tenders)
* Coordinate the creation and/or approval of requested documents (e.g. GMP Certificates, Manufacturing Licenses, GMP Declarations, Inspection reports) with relevant internal and external stakeholders, including Swissmedic
* Archive and maintain the GMP documents
* Document and track all requests in the Interface Portal
* Assess the performance of process and report KPIs
* Participate in Project improvements related to the area (if required)
Must haves:
* Minimum Bachelor Degree in a life science or other relevant technical discipline
* Minimum 3-5 years' experience in the pharmaceutical industry, ideally in Quality Assurance/Management or Drug Regulatory Affairs
* High degree of proficiency in English. German is a plus
* Strong knowledge of business systems that support processes (e.g. Documentum Management Process)
* Sound knowledge of current international Good Distribution/Manufacturing Practices
* Sound knowledge of GMP certification and licensing processes
* Good knowledge of regulatory submission requirements
Personal requirements:
* Proactive Person which a good rational thinking
* Accountable for behaviors as described in Core values
* Expert in delivering results in short term
* Effective oral and written communication and presentation skills
* Ability to make decisions within scope of role or escalate appropriately
* Ability to leverage process oriented thinking
* Establish trust with others, and is known for her/his ethics and integrity
* Oriented to Operation and delivered results in the assigned task
Reference No.: 919399SGR
Role: Documentation Specialist
Industry: Pharma
Location: Basel
Workload: 100%
Start: 29.06.2020
Duration: 3++
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT and Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.