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We are searching for a Specialist Validation. As part of this department, the (QS) Specialist Validation ensures the quality oversight of the process validation activities. Main responsibility is to ensure EO sterilization validation and process validation activities comply with the applicable European and FDA regulations, guidelines and the company’s Global Quality Policies
KEY ACCOUNTABILITIES AND RESPONSIBILITIES
Most of the time, you’ll be involved in maintaining the Process validation and EO Sterilization validation process of the company, more concrete:
- You’ll maintain the QMS procedures on process validation of EO sterilization and manufacturing processes, including the risk management process (process FMEA) to be compliant with applicable European and FDA regulations, guidelines and the company’s Global Quality Policies.
- You’ll train the process validation and EO sterilization validation engineers.
- You’re responsible for maintaining and doing the follow-up of the VMP’s and periodic reviews to ensure that processes are timely re-validated.
- You’ll review and approve EO sterilization validation files for compliance with EN ISO 11135.
- You’ll coach QA engineers in the review process of process validation files and monitor this review process.
- Follow-up EO Sterilisation validation subcontractor
- Responsible for nonconformity handling related to process and sterilisation validation issues (including audit nonconformities)
- investigate CAPA need, guide investigation to the root cause of the nonconformity and review proposed corrective actions.
- Ensure proper documentation and follow-up implementation of corrective actions, effectiveness evaluations for CAPA and closure of the nonconformity.
A smaller part of your time, you’ll execute and support quality systems audits
- You’ll participate in the internal audits of the company
- You’ll support regulatory, corporate and customer audits as subject matter expert for process and sterilization validation, supported by the validation engineers.
- University or technical degree in engineering, scientific, medical or pharmaceutical oriented education, or equivalent by experience.
- Experience in the technical domain of process validation and eager to learn more about EO sterilization (validation). Experience with EO sterilization is an asset.
- Profound knowledge of EN ISO 11135, EN ISO 13485, 21 CFR Part 820, GHTF/SG3/N99-10
- Minimum 2 years professional experience in medical and/or pharmaceutical environment
- Good working knowledge of English (written and spoken). Knowledge of French is an asset.
- Team player with strong communication skills to collaborate with different partners across our organization
- Being able to work accurately according to guidelines
- Open to work full time
WHAT THE COMPANY OFFERS
Working for the company means contributing to society through healthcare.
They offer an attractive salary and benefits package. Besides meal vouchers, interesting insurances, 100% public transport reimbursement, you also have the possibility to lease an (e-)bike.
They offer the opportunity to work in a top performing team. An organisation where everyone is treated with respect. They strive to create a diverse, equal and inclusive work environment. They invest in their associates by offering a broad array of development opportunities, including training in EO sterilization activities.
Linked with their core value Care, the company allows a hybrid way of working, combining office with home-based work. For this role, you’re allowed to work very flexible switching between home or office based. To ensure team connection, presence in the office is asked on Monday for weekly team meeting.