Corporate External Quality Assurance Specialist
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Corporate External Quality Assurance Specialist
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WE ARE HIRING!
Corporate External Quality Assurance Specialist
WE ARE HIRING!
Corporate External Quality Assurance Specialist
Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.
Being part of this team does not mean you are just working for a company, but for a cause!
Neuraxpharm is looking for Corporate External Quality Assurance Specialist for a new product launch based in Barcelona
Your Mission
The Corporate External QA Specialist is responsible for maintaining and improving an effective and efficient quality assurance system that ensures the compliance with current regulations (including but not limited to: GMP, GDP and ICH Quality guidelines) to guarantee that medicinal products manufactured by external contract manufacturing organizations (CMOs) are consistently produced, tested and distributed in accordance with the quality standards appropriate to their intended use and as required by the Marketing Authorization, which ensures the quality, efficacy and security of the medicinal products for patients.
Become the expert regarding the quality along the lifecycle management of the assigned molecules and FDFs, which includes changes in manufacturing and testing, resolving quality incidents, addition of new sources of API and any change that could affect to the manufacturing process related with externals CMOs.
Your Major Accountabilities
* Supervise the quality of the product and drive continuous improvement.
* Support the assigned Product Lifecycle projects.
* Supervise activities of the CMOs.
* Supplier qualification management.
* Execute internal and external audits. Attend audits from Health Authorities and customers.
* Write, review and approve technical documents: SOPs, master batch manufacturing records, analytical methods, material lists, specifications, stability studies, filed dossiers, Quality Agreements, environmental conditions, etc.
* Write, review, approve and monitor CAPAs, deviations, OOS, complaints and change controls.
* Write, review and approve Product Quality Review reports.
* Prepare and execute GMP training.
* Compliance (internal procedures vs filed documentation).
* Write, execute or review qualifications (equipment, utilities and facilities) and validations (e.g. process, cleaning).
* Perform Compliance checks (internal procedures vs filed documentation).
* Execute internal and external audits. Attend audits from Health Authorities and customers.
* Prepare and execute GMP training
* Attend requests regarding quality related to marketed products.
* Participate in the several corporate assigned projects.
We Would Like You To Have
* University Degree in Life Sciences or Engineering
* Minimum experience of 2 years in a Quality Assurance Department in a Pharmaceutical company or similar
* Key Capabilities: Analytical mindset, Communication, Problem Solving and Quality Orientation.
* Expert in GMP and Quality Management System
* Expert user of MS Office, SAP, LIMS
* Availability to travel to conduct audits
* Open mentality to new projects and changes, and commitment with the continuous improvement and promotion of the quality standards established in the company
* Proficiency in English
About Us
Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.
Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.
The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, and globally via partners in more than 40 countries. Neuraxpharm is backed by funds advised by Permira.
Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain.
Be part of the team where you can count on us to deliver:
* Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
* Attractive remuneration according to the experience and skills provided.
* An inspiring leadership team that drives performance.
* An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, a dynamic, a result focused and an expert&excellent team!
Interested in knowing more?
Have a look at what Neuraxpharm culture represents and what makes us a great place to work: www.neuraxpharm.com
If you want to join us, this is your opportunity!
WE COUNT ON YOU!
At Neuraxpharm’s we ensure an inclusive, diverse, safe and respectful work environment for everyone in its organization. As we care for our people as much as we do for our patients, we are committed to guaranteeing a healthy, inclusive and equal opportunity workplace that enables employees to develop their professional potential, while ensuring their individual and collective satisfaction.
We are guided by a Diversity & Inclusion policy to ensure a business culture based on the principles of diversity, equality and inclusion. Our policy complies with European legal regulations and includes the necessary standards, processes and measures to be taken in the event of discrimination or harassment against any employee of the company.
We embrace and promote different cultures, gender identities, seniorities, ages and mindsets within the workplace, to bring different perspectives, styles and experiences to our business.
Seniority level
* Seniority levelAssociate
Employment type
* Employment typeContract
Job function
* Job functionAdministrative
* IndustriesPharmaceutical Manufacturing
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