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Contract Quality Coordinator GMP/GDP - Basel

Employer
Umbilical Life
Location
Canton of Basel-Stadt (CH)
Salary
Negotiable
Start date
1 Oct 2019
Closing date
31 Oct 2019

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Discipline
Quality, GMP, Systems Manager
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Michael Parker at Umbilical life is currently recruiting a Quality Coordinator GMP / GDP for a leading Pharmaceutical / Biotech company based in Basel, Switzerland.

My client is an extremely exciting company that has a start-up feel but with Large Pharma levels of investment and infrastructure. This a 12 month very well-paid contract based on site in Basel.

The client is going through a huge growth phase so the role is expected to grow in line with that. That would also be looking for someone who is looking to stay longer than the initial 12 months. They have a lot of products going through and coming out of clinical phases and now requiring the implementation of QA to GMP / GDP standards.

The role is a position is looking after all areas of Operations QA and has a lot of room for growth. This is an urgent and new role so please get in touch as soon as possible to discuss further.

I have put some information below around the requirements of the role:

Job Description

  • Management of QA related Documents in Veeva, e.g. Validation documentation, QbD documents, MBR, EBR etc.
  • Performs assigned tasks in accordance with applicable QS Documents (e.g. SOPs, WIS etc.)
  • Management Veeva, Reports, Binders, as well as KPI tracking and improvement activities
  • Approval of SAP Master Data, release transactions, extension of shelf life, etc.
  • Support of Supplier Qualification activities, like review of questionnaires, KPI monitoring etc.
  • Support and advise the project team regarding pharmaceutical development related to regulatory strategy for submission
  • Assist GMP/GDP onsite audits at Contract Manufacturing Organizations (CMOs) on demand
  • Support for small projects, e.g. 2nd source suppliers, or Phase I project
  • Preparation and monitoring of Deviations, CAPA, OOS/OOE
  • TQA preparation and monitoring
  • Write, review, and/or approve internal SOP’s and other, according to employee’s expertise
  • Provide quality monitoring and advise to others functions according to employee’s expertise
  • Coordination of complaints
  • Managing archiving of paper based documentation for the QA Department
  • Other administrative task, e.g. preparative work for internal Audits, Quality trending’s, conduction of trainings for other department, etc.

Candidate Requirements

  • University-degree (Master preferred) or equivalent education in the field of chemistry, biochemistry, biology, pharmacy, or chemical engineering
  • At least 1 year  of experience in quality assurance in GMP regulated environment
  • Alternatively experience in other related fields, e.g. analytical / synthetical laboratories or similar operational positions in the pharmaceutical industry
  • Knowledge and understanding of drug substance development, manufacturing process, quality control, packaging and distribution
  • Knowledge of (c)GMP/GDP’s
  • Ability to pro-actively notice, report, and work on quality gaps and quality improvements
  • Advanced SAP knowledge is a plus
  • Ability to independently perform assigned tasks within given timelines. Timely communication of any anticipated delays to meet given timelines
  • Fluent in English and at least basic knowledge of an additional language, German, French or Chinese is advantageous

Company

Umbilical will be a world leading provider of workforce solutions in Science, Technology and Engineering. 

Blending innovation and a commitment to entrepreneurship, we will ensure our customers and colleagues achieve the highest levels of satisfaction.

With nearly 75 years of workforce industry experience between us we know a lot, but not everything. 

We have created a Mission, Vision and a set of clear Values, providing‘guiding light’ as we all start building this Culture, or as we call it the CODE.   

 

Company info
Website
Telephone
011 6 461 0070
Location
Premier House
9 Rutland Street
Leicester
LE1 1RE
United Kingdom

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