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QA Manager - Drug Substance- Freelance / Contract - Basel

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

Job Details

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.

This role will be a stand-alone position and will expect you to work autonomously and really push to ensure QA. The QA Manager will be a specialist in drug substance and based in Basel Switzerland. The role will have a strong GMP focus and manage all areas of QA, deal with CMO's and third parties as well as working across departments. 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.

Please get in touch as soon as possible as this is an urgent contract role. I have put some information below about the responsibilities of this role.

Job Description

  • Provide GMP/GDP quality assurance expertise during development and later during commercialization of products
  • Perform GMP onsite audits at Contract Manufacturing Organizations (CMOs)
  • Prepare GMP/GDP Agreements in collaboration with CMOs and the CMC team
  • Write, review, and/or approve internal SOPs and other GMP/GDP related documentation
  • Ensure that medicinal products are designed, developed, manufactured and controlled according to quality standards
  • Establish a quality risk management approach in projects based on ICH Q9 concepts to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
  • Manage all required activities to support release of active ingredients, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls
  • Notify management of potential quality and regulatory issues
  • For assigned projects, provide guidance on the resolution of complaints, testing issues, discrepancies and Out of Specifications, investigations and Corrective and Preventive Actions as needed
  • Support review and optimization of the company’s pharmaceutical quality system by establishing and preparing review of relevant Key Performance Indicators.

Candidate Requirements

  • Advanced University degree in Pharmacy, Chemistry or alternative technical/science university degree
  • Minimum of 3 years’ experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or similar operational positions in the pharmaceutical industry
  • In addition, minimum of 3 years’ experience in quality assurance activities specific to drug substance
  • Excellent knowledge of GMPs and regulatory environments, ability to interpret and implement quality standards
  • Experience in SAP required
  • Strong interpersonal and influencing skills
  • Excellent verbal and written communication skills in English
  • Ability to manage multiple tasks with competing priorities
  • Entrepreneurial mind set combined with cost consciousness

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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