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HIPRA is a pharmaceutical and biotechnological company focused on prevention and diagnosis for animal and human health, with a broad range of highly innovative vaccines and an advanced diagnostic service.
HIPRA has a solid international presence in more than 40 countries, with its own subsidiaries, 11 diagnostic centres and 6 production plants strategically located in Europe (Spain) and America (Brazil). Research and Development constitute the core of its knowledge.
HIPRA dedicates 15% of its annual turnover to R&D activities that concentrate on the creation and application of the latest scientific advances to the development of the highest quality innovative vaccines. To give added value to its vaccination experience, the company also develops medical devices and traceability services.
We are currently looking for a motivated Quality Assurance specialist Oversight for our offices in Amer, (Girona) to join our team and support the FDA Inspection for Human Health projects.
Main Responsibility
Actively participate in the plant QA oversight regarding aseptic behavior and contamination risk control, as well as to ensure that activities comply with cGMP, corporate policy, local procedures, and regulatory expectations.
Synergically completed the gaps and improvements identified across the organization for the FDA Inspection.
Qualifications
* Bachelor’s degree completed in biology, biotechnology, chemistry, pharmacy or veterinary
* Minimum of 2 years of experience in Quality Assurance in pharmaceutical or biotechnological sector
* Proactive and flexible mindset, eager to contribute to a fast-paced and evolving environment. Easy-going person, able to work in a team and under pression.
* Proficient written and spoken English level.
* Previous experience in FDA process and inspection would be a plus.
* Open to work on rotating morning and afternoon shifts and aseptic conditions
Functions
Actively supervise, on-site, the processes linked to the products manufactured in the Human Health area to ensure compliance with the Good Manufacturing Practices (GMP) and the procedures related to HIPRA's Quality System.
Collect information, analyse processes and work methods with the aim of identifying points for improvement to avoid possible deviations or non-compliance with specifications.
Implement corrective or preventive measures with the aim of resolving non-compliances, improving process efficiency, avoiding risks and ensuring product quality.
Asegurar que se lleven a cabo adecuadamente las investigaciones CAPA relacionadas con su área de responsabilidad, así como el cumplimiento de las acciones derivadas.
Review that deviations from established procedures are documented and investigated to determine the root cause. Ensure that corrective and/or preventive actions are taken, where appropriate, to ensure that such deviations do not recur in the future.
Analyze and monitor critical data and process indicators to ensure robust processes and corroborate the effectiveness of implemented preventive and corrective measures.
Ensure that staff in the supervised area receive general and job-specific training on GMP at the established and necessary intervals and provide some of this training.
Propose ideas for improvement and innovation and implement those that are approved.
Participate in all types of projects affecting the department by contributing ideas and proposals.
REASONS TO BE PART OF HIPRA
To be involved in relevant and long-term projects which provide the opportunity to expand knowledge and experience
Growing multinational company with 40 subsidiaries worldwide.
Multicultural environment within the different teamwork.
Promotion of training and development plans.
Seniority level
* Seniority levelEntry level
Employment type
* Employment typeFull-time
Job function
* Job functionManufacturing and Quality Assurance
* IndustriesMotor Vehicle Manufacturing
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