Requirements: English
Company: 3PBIOVIAN
Region: Noin , Navarre
Are you looking for an opportunity to develop your professional career in a CDMO Quality Control department?
From day one on, 3PBiovian has been inspired from the people that conforms it, and because of that matter, one of the main values of the company has always been the professional and personal growth of its employees in an international and biotechnological environment.
Due to this prioritization, Navarra site of 3PBiovian is currently looking for professionals who want to focus their careers in Quality Control department Biological.
The successful candidate will join 3PBiovian, in Navarra, Spain as part of our Quality Control department.
The candidate will be responsible for:
- Ensure GMP activities in the biological laboratory.
- Evaluate and review the technical documentation corresponding to the Quality Control of the biological laboratory, as well as the analytical results in routine manufacturing, validation and transfer activities.
- Organize and ensure compliance with the weekly program and coordinate human, material and technical resources to ensure its achievement.
- Propose process improvements aimed at improving quality, cost, performance, time and safety of workers and the environment.
- To train and qualify the analysts to carry out the controls correctly.
- Maintain the installations in perfect state of conservation ensuring that they are operated according to the manuals provided by the manufacturer.
- Carry out the drafting and supervision of standard operating procedures (SOP''s) and the resolution of deviations in the laboratory.
- Coordinate the release of raw materials and the analysis of intermediates, drug substances and drug products.
- Support stability studies agreed with our customers in collaboration with other technicians.
- Provide production quality support in case of incidents that may arise.
- Approve and close CAPAS (corrective and preventive actions) arising from deviations and applicable efficacy verification.
- Check the correct traceability of the materials consumed in the analysis process.
- Perform duties as assigned and for which job training has been received.
Assessment criteria:
- Bachelors degree in Pharmacy, Chemical Engineering, Biochemistry or any other related discipline is required.
- Fluent in English is valuable.
At least 4 years in:
- Experience analytical methods such as; SDS-PAGE, Western-Blot, total protein concentration determination, ELISA, qPCR, plant control of water for injection, etc.
- Experience with recombinant proteins, mAbs, Biosimilar, ADCs.
- Experience with pharmaceutical regulatory guidelines.
We offer:
A permanent and stable position in a competitive growing company.
A competitive time off package with 39 paid days of vacation.
Additionally you will have an extra day off on the 26th of December.
Flexible compensation plan, allowing all employees to allocate up to 30% of their gross annual salary to daily services exempt from income taxes (childcare, health insurance, academic training etc.)
Company benefits club, which allows 3P Biovian employees to obtain exclusive prices and discounts on a multitude of products and services (Booking, FNAC, Rituals, El Corte Ingls etc.)
All new hires who reside outside Navarra are provided with a relocation service and/or assistance.
..And so much more!
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