Senior Specialist Extractables and Leachable Validations

Real

Boxmeer

On-site

EUR 60,000 - 80,000

Full time

14 days+

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Benefits offered by this job

Comprehensive benefits package

Opportunities for professional growth

Collaborative work environment

Job summary

A leading company in the pharmaceutical industry is seeking a Senior Specialist for Extractables and Leachable Validations. This role involves providing technical support for quality pharmaceutical products, ensuring compliance with EU GMP regulations, and managing validation programs. The ideal candidate will have a relevant degree and experience in the pharmaceutical sector, along with strong problem-solving and organizational skills.

Qualifications

Experience in the pharmaceutical industry and quality requirements.
Ability to manage complex projects effectively.

Responsibilities

Responsible for method and equipment validation.
Provide ongoing technical support in contamination control.
Execute Extractables and Leachable risk assessments.

Skills

Problem Solving

Interpersonal Skills

Organizational Skills

Continuous Improvement Mindset

Education

Bachelor's Degree

Master's Degree

Tools

Technical Writing

Job description

Senior Specialist Extractables and Leachable Validations

5 days ago Be among the first 25 applicants

About Us: MSD is a leading company in the pharmaceutical industry, dedicated to delivering high-quality products and services. We strive to meet the highest standards of compliance, supply chain management, strategic planning, and profitability.

Job Description: As a Scientific Technical Specialist, you will provide in-line technical support to ensure the continued manufacture and supply of quality pharmaceutical products. This role is crucial in meeting the company's priorities of Compliance, Supply, Strategy, and Profit Plan. The vacancy is created within the Boxmeer Center of Excellence Quality Operations team and is part of the Global Packaging Center of Excellence (CoE) activities. You will work closely with the Boxmeer Filtration team to help complete the sterile filter validations in accordance with EU GMP Annex 1 regulations.

Responsibilities:

Responsible for all aspects of method and equipment validation.
Assist in the effective and efficient running of the method and equipment validation programs.
Provide ongoing technical support to the site in the area of contamination control.
Execute Extractables and Leachable risk assessments on behalf of the manufacturing unit.
Occasionally perform additional tasks as provided by the Global Packaging CoE team.

Qualifications:

A completed Bachelor's, Master's, or higher degree in Biology, Chemistry, Pharmacy, or a related scientific discipline.
Strong and relevant experience in the pharmaceutical industry and its quality requirements.
Technical writing experience such as SOPs, protocols, deviations, CAPAs, assessments considering GMP rules.
Responsibility for executing Extractables and Leachable risk assessments.
Strong problem-solving skills, with a proven ability to manage complex projects effectively.
Ability to work both independently and within multi-functional teams.
Business proficient knowledge of the English language is mandatory.
Strong organizational skills and ability to manage multiple tasks at one time, including the ability to follow assignments through to completion and meet timelines.
Living at a reasonable distance from Boxmeer.
Interpersonal skills and ability to build relationships with colleagues across departments.
Continuous Improvement Mindset and openness to learning.

What We Offer:

Comprehensive benefits package including [e.g., healthcare, pension plan, etc.].
Opportunities for professional growth and development.
A stimulating and collaborative work environment.

Seniority level