Requirements: English
Company: 3PBIOVIAN
Region: Noin , Navarre
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.
- To 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:
- Bachelors 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?
- 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 Ingls, etc.).
- Flexible working hours during the week and a reduce 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. To this end, we have Learning & Development department, who is in charge of creating personalized, individualized and differentiating career plans for our employees.
- The company continues to focus on internal talent and stable employment, focusing on upskilling and reskilling. 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, social donations...
- We have several programs aimed at improving the physical, psychological and emotional well-being of our employees. In this context, we participate in the Corporate Challenge, promote healthy lunches and comfortable and safe work spaces.
- 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.
Why us?
We know it takes people with passion and a shared purpose to manufacture advanced medicines.
We specialize in process development and cGMP manufacturing of biologics and cell therapy products using microbial and mammalian expression systems. We are with you on your biologics journey, growing with you and supporting you with process and analytical development, preclinical and clinical supply, and commercial production. With a focus on biotechnology applications in both human an animal health sectors, we offer customized solutions that meet the specific needs of all our clients
From development to product delivery, we are with you on your biologics journey. We are a leading global CDMO and preferred partner for pharmaceutical and biotech companies. We have what it takes to help you improve lives.
It''s within us.