Vulcain Engineering Belgium is looking for a QC Specialist to join its team.
ABOUT THE POSITION:
* Support GMP activities in the laboratory such as
* Change control creation and follow up
* Actions follow up
* Training matrix review and documentation
* Protocol, study execution and report for compendial feasibility, or transfert and validation documentation
* Update/review of laboratory documentation: analytical methods; analytical instructions;
* coaching’s modules,…
* Ensure follow-up and compliance of procedures and instructions, and update if needed.
* Ensure follow-up of corrective actions and preventive actions.
* Support product launches and prepare documentation requested by authorities
* Update of batches documentation according to specifications
* Support documentation linked to in process analyses
EXPERIENCE:
* Expertise in the pharmaceutical industry.
* Experience in GMP
* Strong organization skills with proven records
* Proven project leadership skills including planning, monitoring, compendial verification with protocol and reports, decision making and reporting;
* Proven experience in documentation creation, update to support QC activity
* Ensure required corrective actions are taken and put in place and lead the implementation in collaboration with the QA, team leaders and technicians
* Understanding of all analytical disciplines related to CMC for late stage development and commercial products (analytical development, stability testing and quality control of drug substance, drug product, raw material and intermediate).
ABOUT YOU:
* Master’s degree in life sciences or any related field
* 3 to 8 years of experience in the pharmaceutical industry
* Good knowledge of GMP rules
* Good knowledge of the V-cycle
* Autonomous, conscientious and positive problem-solving mindset
* Fluency in French and English is mandatory.
ABOUT US:
Vulcain Engineering is a group specialized in the energy sector that supports companies active in Renewable & Nuclear Energy, Gas & Infrastructure through our Study Offices and Consultancy services. Vulcain Engineering Group is positioned as a transformation partner thanks to its ultra-specialization in strategic sectors which positively impact the transformation of our society and supports its clients in their transformation towards more sustainable and responsible models. Vulcain supports its clients throughout the entire life cycle of their projects, from design to commissioning, by integrating constructability and safety requirements right from the design phase.
In Belgium, our activities focus on consultancy services, delivering expertise in three main areas:
* Energy/Infrastructure
* Gas Renewables & Processes
* Life Sciences
With headquarters based in Brussels, and clients spread all over the country, we address key projects in the Belgian industry, offering our consultants the opportunity to work on challenging topics and discover different areas during their time at Vulcain.
Why would you apply?
* A competitive package including gross salary ranging from €44,000 to €67,000 paid over 13,92 months and advantages such as a company car (and fuel card), representation fees, insurances, meal vouchers, eco cheques, a sectorial bonus. (The salary indicated corresponds to the level of experience mentioned in the job description. For any other level of experience, the annual salary may vary accordingly).
* A tailored career path within the company : opportunities to discover different business units, training, follow-up from your business manager, and a development evaluation every year
* A human-based company with slightly more than 120 consultants and synergies between the different business units