QA Validation Consultant – Pharma - Akka Technologies - BELGIUM

Job description

QA Validation Consultant

For one of our clients, a multinational pharmaceutical and biotechnology company, we are actively looking for a QA Validation Consultant.

Purpose of the Mission

Provide QA support and oversight to validation activities according to validation procedures.

Key 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 the company’s Vaccines 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 reviewing deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities (Approval must be performed by internal employee)

Pro-actively identify potential quality and compliance

Work in autonomy with 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

Profile

Experience:

Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
Knowledge of GMP / CFR / EudraLex …
Knowledge of different regulations and standards related to validation activities

Soft skills:

Good interpersonal relationship skills
Problem solving and achievement oriented
To be a good team player in order to succeed in each validation project and routine activities
To be able to use a risk-based approach for problem solving and prioritization of tasks

Knowledge:

SAP, documentum is an asset.

Education:

University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)

Language Proficiency Requirements

French - Fluent oral and written communication skills
English - Good oral and written communication skills

Offers “Akka Technologies”

Job description