QA Scientist for Batch Release
hace 4 semanas
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 to 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 to promoting diversity, gender-equality, well-being, and initiative within its members, encouraging career development and internal promotion.
The QA Scientist will be assigned the following responsibilities:
- Be involved in the revision of manufacturing batch records and packaging batch records and other batch review documents of pharmaceutical products to be released.
- Participate in the evaluation of deviations, OOS/OOT, complaints, CAPA and Change Controls of pharmaceutical products to be released ensuring the application of GMPs and according to the marketing authorisation or clinical trial authorisation.
- Participate in the certification process of batches susceptible to be released to the market or for clinical trials.
- Review of Quality/Technical Agreements between the company and manufacturers and marketing authorisation holders, especially with regard to batch certification activities.
- Review and approve the documentation involved in the activity of the company: CoA, Site Master File, SOPs, product specifications.
- Collaborate and participate in the revision of audit reports carried out by third-parties to the manufacturers of pharmaceutical products to be released.
- Collaborate in audits carried out by our clients and give support in the Inspections of regulatory authorities.
- Participate in the implementation and improvement of the quality system of the company.
We are looking for a candidate with a Life Sciences Degree, preferably with Pharmacy Degree, and with 2 years of experience in Quality Control or Manufacturing activities in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry. Experience on 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 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 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.
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
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