Senior Quality Assurance Technician Marbella
The successful candidate will join 3PBiovian as a Senior Quality Assurance Technician.
Main responsibilities:
* Achieve the objectives set by the Quality Assurance and Regulatory Affairs Department.
* Cooperate in compliance with the NCFs and the Quality System implemented at 3PBiovian.
* Prepare and review deviations, change controls, risk management, corrective or preventive actions, AMB, OOS, OOT, OOL, customer and supplier claims, etc., or those documents that are considered to require a review by Quality Assurance.
* Provide support to the Quality Assurance department in audits of clients and regulatory authorities.
* Carry out the functions assigned and for which training has been received, of the job position.
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. Methodical, DPR, MPR, etc.
* 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?
* 26 paid days off: 23 vacation days + 2 personal days + 1 day off set by the company.
* Flexible compensation plan, allowing all employees to allocate up to 30% of their gross annual salary to daily services exempt from income tax (childcare, health insurance, training, etc.).
* Company benefits club, which allows 3P employees to obtain exclusive prices and discounts on a multitude of products and services (Booking, Fnac, Rituals, El Corte Inglés, etc.).
* Flexible working hours during the week and a reduced work day on Friday of 7h.
* Special Summer working day of 7h during July and August.
* 3PBio is committed to the continuous, updated and personalized improvement of our personnel's learning. We have a Learning & Development department, which is in charge of creating personalized, individualized and differentiating career plans for our employees.
* The company focuses on internal talent and stable employment, emphasizing upskilling and reskilling. We offer opportunities for professional growth in an environment of trust.
* We encourage the participation of our employees in solidarity events such as charity races and social donations.
* Programs aimed at improving the physical, psychological and emotional well-being of our employees are in place, including participation in the Corporate Challenge and promoting healthy lunches and comfortable workspaces.
* A high-impact work environment with flat hierarchies and short decision-making processes.
* Relocation service and/or assistance for new hires residing outside of Navarra.
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