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GMP QA Qualification Engineer - French Speakers

Employer
i-Pharm Consulting
Location
Liège, Belgium, Verviers
Salary
EUR70 - EUR75 per hour
Start date
31 May 2023
Closing date
13 Jun 2023

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Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Job Title: QA Qualification Engineer - French Speaker Location: Verviers, Belgium

Contract: 7 Months Hours: 40 hours P/W Salary: 600EUR per day, Umbrella/Freelance

Please note: this role does not offer any VISA sponsorship, to be eligible for the role you must be able to work in the EU without sponsorship or restriction.

i-pharm consulting is working with a global pharmaceutical company who are a preferred global partner to the pharmaceutical, biotech and nutrition markets. They focus on enabling treatments that prevent illness and support healthier lifestyles and optimize scientific innovation and manufacturing technology to enable our customers to serve their patients and consumers. We are looking for a QA Qualification Engineer to join them at their site in Verviers, Belgium.

Description:

  • Ensure compliance with all applicable cGMP and ISO requirements.
  • Ensure 21 CFR part 11 and 21 CFR 820 compliance. EudraLex vol IV annex 1
  • Ensure the Qualification and Requalification of a family of Equipment, Utilities
  • Ensure compliance with all applicable internal and external guidelines and standards
  • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
  • Participate in the management of compliance critical functions including quality systems, change control, deviations, training, internal audit, validation support, document control, supplier quality, quality agreements, computer system validation, E&M documentation and regulatory and customer audit program for the site
  • Make independent quality related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams
  • Assist in change control checklist review/approval for changes related to systems/equipment's, approve the change control and review the delivered evidence to close out the change control
  • Provide oversight for compliance of CAPA, investigation, OOQ, change control and deviations related to technical issues
  • Conduct periodic internal reviews or audits to ensure that compliance procedures are followed
  • Independently identify and manage special compliance projects.
  • Review and approve and ensure compliance of the GMP Engineering, qualification, maintenance and calibration documentation: FAT, SAT, IQ, OQ, PQ, Qualification Summary Reports
  • Review and approve incidents / deviations initiated during qualification
  • Review and approve periodic reviews, requalification's and ongoing support of qualified systems
  • Review and approve validations (cleaning validation, process validation …) performed by the MSAT department.
  • Plan and follow-up of external contractors performing on-site (re-)qualification testing as a backup of the Qualification Engineer
  • Support as a Subject Matter Expert the execution of the (re-)qualification of thermal mappings of thermal equipment (e.g. freezer, fridge, incubators...) and process equipment (e.g. autoclave) and HVAC systems
  • Write qualification/validation protocols (IQ, OQ …) in collaboration with engineering department
  • Review and approve for protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports.
  • Assist in generating validation master plan (VMP) and related validation plan (VP) for the technical departments
  • Assist in FAT /SAT execution with focus on qualification related items.
  • Review, approve and ensure compliance of engineering, maintenance and calibration documents (e.g. calibration certificates, maintenance reports, maintenance and calibration planning ...)
  • Support technical department to write and review qualification/validation related documents
  • Review and approve of OT related qualification/validation documents
  • Follow up of planning for execution of the qualification/validation activities with the different department such as production, maintenance, engineering, CAL/VAL, MSAT … as a backup of the Qualification Engineer.

Education/Certification

  • Master's degree in the field of Engineering
  • GMP compliance knowledge including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others

Language(s)

  • Fluent in French
  • Fluent in English

If you are interested in finding out more about this role or others, please contact Manpreet Bhullar at mbhullar@i-pharmconsulting.com or call: +44 (0)20 7551 0802 / NL: +31 20 809 0665.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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