Senior Quality Assurance Technician
Pontevedra, Galicia, ES
The successful candidate will join 3PBiovian as a Senior Quality Assurance Technician. The main responsibilities include:
1. Achieve the objectives set by the Quality Assurance and Regulatory Affairs Department.
2. Cooperate in compliance with the NCFs and the Quality System implemented at 3PBiovian.
3. Prepare and review deviations, change controls, risk management, corrective or preventive actions, AMB, OOS, OOT, OOL, customer and supplier claims, etc.
4. Provide support to the Quality Assurance department in audits of clients and regulatory authorities.
5. Carry out the functions assigned for which training has been received.
6. Review the documentation associated with the GMP lot.
7. Review the documentation associated with the Cellular Bank batch.
8. Prepare GMP stability studies: review protocols and reports.
9. Issue quality system documentation to carry out the activities of other departments.
10. Review the Process In Progress Verification and the Cleaning In Progress Verification.
11. Prepare Product Quality Review.
12. Review product specifications.
Assessment criteria:
1. Bachelor’s degree in Pharmacy, Chemical Engineering, Biochemistry or any other related discipline is required.
2. Previous experience working for a CDMO is desirable.
3. 5 years of experience in quality assurance activities.
4. Expert in GMP regulations.
5. Fluent in English is desirable.
Why 3PBiovian?
You will have 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 workday 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 offer opportunities for professional growth and take an environment of trust.
We encourage the participation of our employees in solidarity events such as charity races and social donations. We have several programs aimed at improving the physical, psychological, and emotional well-being of our employees. In this context, we promote healthy lunches and comfortable and safe workspaces. We have a high-impact work environment with flat hierarchies and short decision-making processes. All new hires who reside outside of Navarra are provided with a relocation service and/or assistance.
About Us:
We specialize in process development and cGMP manufacturing of biologics and cell therapy products using microbial and mammalian expression systems. We are a leading global CDMO and preferred partner for pharmaceutical and biotech companies.
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