For more than 19 years, through our consulting and engineering activities, we have supported our clients throughout the entire lifecycle of biotechnology, pharmaceutical and device products.
Part of an organization of more than 750 Life-science experts, Consultys Switzerland supports and develops talented individuals recognized for their technical and scientific expertise. Our activities allow us to be present in both French-speaking and German speaking Switzerland, with agencies in Lausanne and Basel.
At Consultys, we're proving that it's possible to combine people and performance.
Much more than concepts, our 3 values "Respect, Recognition and Transparency" guide us and are the foundation of our history, the heart of our group's success.
As part of our development, we are recruiting a QA Validation Consultant to join our teams in Neuchatel.
Responsibilities:
* Review of validation protocols:
* Assess validation protocols related to equipment, processes, CIP, SIP, computerized systems, and HVAC/Utilities.
* Ensure compliance with GMP requirements, internal company standards, and international regulatory guidelines (FDA, EMA, etc.).
* Validation report review:
* Evaluate validation results to confirm that all requirements defined in the protocols are fully met.
* Identify discrepancies and propose corrective actions when necessary.
* Quality support:
* Collaborate closely 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.
Your Profile:
* Degree in a scientific field (pharmacy, biotechnology, chemistry, or equivalent).
* 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.
* Experience in filling line, freeze-dryer validation is a plus.
* Strong knowledge of GMP standards and international regulations (FDA, EMA, ICH).
* Familiarity with risk management methodologies (Risk Assessment) and validation protocols (IQ, OQ, PQ).
* Analytical mindset and attention to detail in document reviews.
* Excellent communication skills to effectively collaborate with multidisciplinary teams.
* Solution-oriented approach and ability to manage multiple projects under tight deadlines.
* Oral and written skills in English and French.
Do you want to join the consulting world in a human-sized company that values the individual and performance?
To share your skills within a cohesive team where experiences are freely shared?
CONSULTYS is open to all talents and is committed to diversity and inclusion.
Seniority Level
Associate
Employment Type
Full-time
Job Function
Quality Assurance
Industries
Business Consulting and Services and Biotechnology Research
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