Principal Pharmaceutical Quality Assurance Specialist For Release

hace 1 mes


Barcelona, Barcelona, España Kymos Group A tiempo completo
About Kymos Group

We are a dynamic and growing company located in the heart of Barcelona, offering a unique opportunity for a motivated individual to join our team as a Principal Pharmaceutical Quality Assurance Specialist for Release.

Salary

The estimated annual salary for this position is between €60,000 - €80,000, depending on experience and qualifications.

Job Description

As a Principal Pharmaceutical Quality Assurance Specialist for Release, you will be responsible for ensuring the quality and integrity of pharmaceutical products throughout their lifecycle. Your key responsibilities will include:

  • Reviewing and revising manufacturing batch records and packaging batch records to ensure compliance with Good Manufacturing Practices (GMPs).
  • Evaluating deviations, out-of-specification (OOS) and out-of-trend (OOT) results, complaints, corrective and preventive actions (CAPA), and change controls to ensure adherence to GMPs and marketing authorization or clinical trial authorization.
  • Certifying batches for release to the market or for clinical trials.
  • Reviewing and approving documentation related to batch certification activities, including certificates of analysis (CoA), site master files, standard operating procedures (SOPs), and product specifications.
Required Skills and Qualifications

To be successful in this role, you should have a Life Sciences degree, preferably with a Pharmacy degree, and at least 2 years of experience in Quality Control or Manufacturing activities in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry. Experience in biologicals will be highly valued.

You should also possess 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.

Benefits

We offer a range of benefits to support your career growth and well-being, including:

  • Flexible working hours and an intensive schedule on Fridays.
  • Hybrid work arrangement with primarily office-based work.
  • Access to our employee benefits flexibility platform.
  • 23 vacation days per year, plus December 24th and 31st.
  • Fully stocked canteen and rooftop space with coffee, fruits, snacks, and beverages.
Our Values

We consider diversity and inclusion key development priorities at Kymos Group, and we strive to promote a culture that celebrates unique talents. We are committed to equal opportunities for all people, regardless of gender, nationality, sexual orientation, gender identity, age, religion, or any other personal characteristic.



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