drjobs Method development and Transfer Specialist Chromatography

Method development and Transfer Specialist Chromatography

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1 Vacancy
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Job Location drjobs

Braine-l'Alleud - Belgium

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

The Method Validation and Method Transfer Specialist will play a crucial role in the validation verification and transfer of analytical methods within the company. The ideal candidate will have substantial experience in analytical method validation/verification in the pharmaceutical industry and a strong understanding of Compendial and ICH requirements. This position requires basic knowledge of statistics and the ability to manage a diverse portfolio of activities including planning resource estimation risk identification decision making communication and team leadership.

Key Responsibilities:

  • Conduct and oversee analytical method validation verification and transfer activities in accordance with regulatory guidelines and company standards.
  • Ensure compliance with Compendial (USP EP JP) and ICH requirements for analytical methods.
  • Develop and execute method validation protocols and reports.
  • Perform statistical analysis and interpretation of validation data.
  • Coordinate crossfunctional teams to ensure timely and successful method transfers.
  • Identify and mitigate risks associated with method validation and transfer activities.
  • Plan organize and manage resources effectively to meet project timelines.
  • Communicate project status issues and risks to stakeholders and senior management.
  • Participate in internal and external audits and regulatory inspections.

Qualifications :

  • Bachelors or Masters degree in Chemistry Biochemistry Pharmaceutical Sciences or a related field. 
  • Minimum of 1 year of experience in analytical method validation/verification within the pharmaceutical industry.
  • Experience with chromatographic techniques (HPLC GC) and spectroscopic methods (UV IR).
  • Good knowledge of Compendial and ICH requirements.
  • Familiarity with regulatory submission processes.
  • Experience with Laboratory Information Management Systems (LIMS).
  • Strong project management skills including planning resource estimation and risk management.
  • Excellent communication and interpersonal skills.
  • Detailoriented with strong problemsolving skills.
  • Proficiency in Microsoft Office Suite and relevant analytical software.
  • Ability to communicate in both English and French.


Additional Information :

  • A fulltime 40hours/week) Monday Friday job.
  • Job location: Braine lalleud 50 and Lessines 50
  • A Permanent contract with flexible working hours.
  • Work in a fastgrowing international organization.
  • Meal Vouchers 8 Euro/Working Day.
  • EcoCheques / 250 Euro/Year.
  • Company car Fuel tank card. 
  • DKV Hospitalization insurance.
  • Additional 12 ADV days.
  • A company wellbeing program targeting both mental and physical wellbeing.
  • A fantastic team with monthly team lunches fun teambuilding activities (laser tag escape rooms sports etc. and above all; a great collaborative international work environment
  • Personal development through learning on the job and additional trainings.

What Happens Next
 

Our people are the backbone of what we do so its incredibly important we find the right individuals to join us. As a potential new recruit youll be invited to meet the team in the form of an assessment center or a staged interview process dependent on the role and its requirements this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths. 
 
Your data 
 

As part of any recruitment process the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.
 
Closing Date

 
We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible.
 
Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately on this occasion your application has been unsuccessful. 


Remote Work :

No


Employment Type :

Fulltime

Employment Type

Full-time

Company Industry

About Company

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