QA Validation Expert Job Description
The QA Validation Expert plays a critical role in ensuring regulatory compliance and quality assurance for processes and equipment within a pharmaceutical industry operating under GMP (Good Manufacturing Practices).
This expert works closely with technical teams to review and approve validation protocols, guaranteeing the safety, efficiency, and reliability of pharmaceutical products.
Main Responsibilities:
* Review of Validation Protocols:
* Assess validation protocols related to equipment, processes, CIP, SIP, computerized systems, and HVAC/Utilities.
* Evaluate compliance with GMP requirements, internal company standards, and international regulatory guidelines (FDA, EMA, etc.).
* Ensure that all requirements defined in the protocols are fully met through validation results.
* Identify discrepancies and propose corrective actions when necessary.
Quality Support:
* Collaborate with technical departments (Production, Engineering, Validation, etc.) to foster an integrated quality approach.
* Participate in project meetings and provide expertise on quality aspects related to validations.
Required Skills and Qualifications:
* Education:
* Degree in a scientific field (pharmacy, biotechnology, chemistry, or equivalent).
* Experience:
* Significant experience (2 years or more) in a similar role within the pharmaceutical industry, in a GMP environment.
* Expertise in process, equipment, CIP, SIP, computerized systems validation.
* Familiarity with filling line and freeze-dryer validation is beneficial.
* Technical skills:
* Strong knowledge of GMP standards and international regulations (FDA, EMA, ICH).
* Familiarity with risk management methodologies (Risk Assessment) and validation protocols (IQ, OQ, PQ).
* Personal skills:
* Analytical mindset and attention to detail in document reviews.
* Excellent communication skills for effective collaboration with multidisciplinary teams.
* Solution-oriented approach and ability to manage multiple projects under tight deadlines.
* Oral and written proficiency in English and French, fluency is highly valued.
About the Role:
* Opportunity to work in a leading pharmaceutical company, enhancing technical and regulatory expertise.
* Involvement in critical projects for product quality and adherence to international standards.