Qa & Validation Consultant

il y a 3 semaines


Bierges, Belgique Oxford Global Resources Temps plein
For one of our clients, a pharma company located in the Walloon Brabant, we are looking for an experienced QA & Validation Consultant. Job Description As QA & Validation Consultant, you provide QA support and oversight to validation activities according to our client's validation procedures. Responsibilities Provide a compliance expertise in validation:
Ensure QA oversight in validation activities (IQOQ / PQ / PV…) Review/Approve the validation documentation regarding the GMP requirements and our client's procedures Ensure that production practice are aligned with validation conclusion Attend all project meetings as QA validation representative Ensure timely escalation to Management of critical issues during validation Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process Work in autonomy with our client's supervision/coaching:
To define the validation strategies through the change control process To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis, Periodic review ….) To ensure the correct application of the validation quality systems in the field and to define improvement plan as required To support the production, QA and technical service teams in the implementation of the validation activities. Requirements University degree (Biotechnology, Agronomy, Chemistry, Pharmacy or related). Existing experience in QA & Validation within a biopharmaceutical industry. Knowledge of GMP/CFR/Eudralex. Knowledge of different regulations and standards related to validation activities. ICT Skills (software, operating systems, hardware, etc.) Fluent in English and in French Problem solving and achievement oriented To be able to use a risk-based approach for problem solving and prioritization of tasks Good team player in order to succeed in each validation project and routine activities Benefits A balanced salary package based on your skills and experience Hybrid working opportunity Permanent contract
  • QA Validation Specialist

    il y a 3 semaines


    1301 Bierges, Belgique Oxford Global Resources Temps plein

    For one of our clients, a pharma company located in the Walloon Brabant, we are looking for an experienced QA & Validation Consultant. Job Description As QA & Validation Consultant, you provide QA support and oversight to validation activities according to our client's validation procedures. Ensure QA oversight in validation activities (IQOQ / PQ / PV…)...