Freelance/Contract Senior Quality Validation Consultant, Nijmegen

Freelance/Contract Senior Quality Validation Consultant Overview We are supporting a Pharmaceutical brand with urgent needs for an experienced Senior Quality Validation Consultant on a freelance/contract basis. This project is expected to be 1.0 FTE (approximately 40 hours per week) with some flexibility for less, and requires immediate availability for at least 6 months. The successful applicant is expected to be onsite in the East of the Netherlands for 4 days per week and must be an independent consultant.

Responsibilities

Provide QA expertise regarding the high containment isolator fill line, including support equipment such as an autoclave, freeze dryer, and vial washer.

Provide QA expertise for new building construction including cleanrooms and utilities (PW, WFI, nitrogen, compressed air).

Ensure quality is considered in the design, including material flow, personnel flow, and aseptic controls.

Ensure project deliverables meet regulatory standards and quality requirements.

Support commissioning, qualification and validation of the high containment isolator fill line for OEB4 substances, including supporting equipment.

Support qualification activities for new cleanrooms and utility systems.

Contribute QA expertise for VHP sterilization, steam sterilization, and freeze-drying processes.

Contribute expertise related to environmental monitoring.

Contribute data integrity expertise.

Review and contribute to qualification protocols and validation documentation.

Support commissioning and qualification activities.

Contribute to container closure system validation for vials, syringes, and cartridges.

Assist with regulatory documentation and inspection readiness.

Skills required

Must be educated to a BSc or higher within a life-sciences or engineering discipline.

Thorough experience working in Quality Validation within the Pharmaceutical industry (7 years or more).

Demonstrated expertise in isolator systems and cleanroom environments.

Aseptic filling line validation exposure is required.

Skilled in various equipment within cleanroom environments (freeze dryers, filling equipment, autoclaves, etc.).

Ability to attend and work onsite in the East of the Netherlands for 4 days per week.

Additional Information We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Consulting, Quality Assurance, and Science

Industries

Pharmaceutical Manufacturing

Biotechnology Research

Medical Equipment Manufacturing

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