We are hiring a Qualified Person (QP) for our Quality Assurance Department.
The Qualified Person (QP) will be assigned the following responsibilities: Review and approve the documentation involved in the analytical activity of the company: CoA, Site Master File, SOPs, product specifications.
Participate and be involved in the revision of manufacturing batch records and packaging batch records and other batch review documents of products to be released.
Participate in the certification of batches susceptible to be released to the market (QP release) and ensure the application of the GMP according to the marketing authorization of the finished drug product.
Participate in the certification of investigational medicinal product batches susceptible to be released for a clinical trial and ensure the application of the GMP according to the investigational medicinal product Dossier.
Participate in the evaluation of deviations, OOS/OOT, complaints, CAPA, and Change Controls.
Review Quality/Technical Agreements between the company and subcontractors, especially with regard to batch certification activities.
Collaborate in audits carried out by our clients or subcontracted manufacturers and provide support in the inspections of regulatory authorities.
Participate in the implementation and improvement of the quality of the company and subcontractors.
We are looking for a candidate experienced as Qualified Person or deputy QP or a candidate with a Pharmacy Degree and with 2 years of experience in Quality Assurance, Quality Control, or Manufacturing in the Pharmaceutical Industry.
Experience with Biologicals will be highly valued.
The candidate should have knowledge in Pharmaceutical Analysis, Quality Control, Manufacturing, and Quality Assurance following the requirements of Good Manufacturing Practices.
A high level of English, both written and spoken, is required for this position.
If you join us, you will enjoy: Working in a dynamic company with a highly qualified growing team.
Professional development and a collaborative environment with a culture of empowerment.
Flexible Working Hours and an intensive schedule on Friday.
Hybrid work, but mainly in the office.
Access to the employee benefits flexibility platform.
23 vacation days per year plus the 24th and 31st of December.
Fully stocked canteen and rooftop space (coffee, fruits, snacks, and beverages).
Our headquarters located in Cerdanyola del Vallés, an amazing place at the foothill of Collserola Park, the green lung of Barcelona, with our Rooftop terrace.
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