QA Scientist for GMP

Kymos Group; Barcelona; Híbrido; EUR 42.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible Working Hours

Hybrid work model

23 vacation days + 24th and 31st of de

Canteen and rooftop space

Headquarters near Barcelona

Descripción de la vacante

Kymos Group invites a Quality Assurance Scientist to join our GMP area within the QA Department, located near Barcelona, Spain.

The role focuses on reviewing and approving analytical documentation, auditing processes for cGMP compliance, supporting self-inspections, evaluating deviations and CAPA, and assisting regulatory inspections. You will collaborate with cross-functional teams in a hybrid work setting.

Formación

• Bachelor's degree or higher in chemistry, pharmacy, biosciences or related field.
• At least 1 year of experience in QA, QC or manufacturing in the pharmaceutical industry.
• Knowledge of Pharmaceutical Analysis, Quality Control and Quality Assurance per cGMP.
• High level of English (written and spoken).

Responsabilidades

• Review and approve analytical documentation (CoA, protocols, reports, SOPs, product specifications).
• Audit analytical documentation to ensure compliance with cGMP standards.
• Participate in the QA Annual Program of self-inspections.
• Verify conformity of quality controls in company processes.
• Evaluate deviations, OOS/OOT, complaints, CAPA and Change Controls.
• Review Quality/Technical Agreements with subcontractors, esp. batch certification activities.
• Collaborate in audits by clients or subcontracted manufacturers and support regulatory inspections.
• Participate in implementation and improvement of quality across the company and subcontractors.

Conocimientos

Quality Assurance

Quality Control

GMP knowledge

English proficiency

Educación

Degree in Chemistry

Degree in Pharmacy

Degree in Biosciences

Descripción del empleo

We are hiring a Quality Assurance Scientist for our GMP area of Quality Assurance Department.

The QA Scientist will be assigned the following responsibilities:

• Review and approve the documentation involved in the analytical activity of the company: CoA, protocols, reports, SOPs, product specifications.
• Auditing the analytical documentation issued by the operative area to ensure the compliance to the internal and external standards according to cGMP regulations.
• Participate in the QA Annual Program of self-inspections.
• Verify the conformity of quality controls established in the company’s processes.
• Participate in the evaluation of deviations, OOS/OOT, complaints, CAPA and Change Controls.
• Review of the 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 give support in the Inspections of regulatory authorities.
• Participate in the implementation and improvement of the quality of the company and subcontractors.

Requirements:

Requirements:

We are looking for a candidate with Degree in chemistry, pharmacy, biosciences or related and with at least 1 year of experience in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry.

• The candidate should have knowledge in Pharmaceutical Analysis, Quality Control 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 collaborative environment and a culture of empowerment.
• Flexible Working Hours and intensive schedule on Friday.
• Hybrid work, but mainly in the office.
• Access to the employee benefits flexibility platform.
• 23 vacation days per year plus 24th and 31th 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.

Kymos considers diversity and inclusion as key development priorities, with one of our main goals being to promote a culture that embraces differences and celebrates unique talents. For this reason, we are committed to equal opportunities for all people, regardless of gender, nationality, sexual orientation, gender identity, age, religion or any other personal characteristic.