23 feb
Importante Empresa Del Sector
Estado de México
The successful candidate will join 3PBiovian as a Senior Quality Assurance Technician.
Main responsibilities include: Achieving the objectives set by the Quality Assurance and Regulatory Affairs Department.
Cooperating in compliance with the NCFs and the Quality System implemented at 3PBiovian.
Preparing and reviewing deviations, change controls, risk management, corrective or preventive actions, AMB, OOS, OOT, OOL, customer and supplier claims, etc., or those documents that require a review by Quality Assurance.
Providing support to the Quality Assurance department in audits of clients and regulatory authorities.
Carrying out the functions assigned and for which training has been received.
Specifically:
Review the documentation associated with the GMP lot.
Review the documentation associated with the Cellular Bank batch.
Prepare GMP stability studies: review protocols and reports.
Issue quality system documentation to carry out the activities of other departments.
Review the Process In Progress Verification and the Cleaning In Progress Verification.
Prepare Product Quality Review.
Review product specifications.
Assessment criteria: Bachelor's degree in Pharmacy, Chemical Engineering, Biochemistry or any other related discipline is required.
Previous experience working for a CDMO is desirable.
5 years of experience in quality assurance activities.
Expert in GMP regulations.
Fluent in English is desirable.
Why 3PBiovian?
27 paid days off: 24 vacation days, 2 personal days, 1 day off set by the company.
Flexible compensation plan, allowing allocation of up to 30% of gross annual salary to daily services exempt from income tax (childcare, health insurance, training, etc.).
Company benefits club offering exclusive prices and discounts on various products and services.
Flexible working hours and a reduced workday on Fridays.
Special Summer working day during July and August.
Commitment to continuous learning and development with personalized career plans.
Opportunities for professional growth in a supportive environment.
Participation in solidarity events and programs aimed at improving employee well-being.
Relocation service and/or assistance for new hires residing outside of Navarra.
We specialize in process development and cGMP manufacturing of biologics and cell therapy products.
We are a leading global CDMO and preferred partner for pharmaceutical and biotech companies.
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