QA Scientist for GMP

KYMOS GROUP is a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain, Italy, and Germany and a Liasson office in South Korea, offering comprehensive bioanalytical and CMC analytical services to the life sciences industry. Its laboratories are GMP and GLP certified and GCP compliant, and have been successfully inspected by EMA, FDA, and ANVISA.

KYMOS GROUP is devoted in providing high quality and added value services to its partners and it is highly oriented to innovation, offering services of research, development and quality control in many different fields such as small molecules, proteins, antibodies, nucleic acids, and advanced therapies.

KYMOS GROUP has a young and dynamic staff of more than 200 employees, and it is committed in promoting diversity, gender-equality, well-being, and initiative within its members, encouraging career development and internal promotion.

We are hiring a Quality Assurance Scientistfor 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 D egree 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.

Sector: Pharmaceutical and biopharmaceutical