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Corporate Cold Chain QA And Tech Transfer Specialist
hace 6 horas
WE ARE HIRING
CORPORATE COLD CHAIN QA AND TECH TRANSFER 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 a Corporate Cold Chain QA and Tech Transfer Specialist, focused on Infudopa SubC, based in Barcelona
(Corporate role)
Your mission:
This role will act as an expert in quality control and manufacturing for assigned molecules and finished dosage forms (FDFs). This includes managing changes in manufacturing and testing, resolving incidents, adding new API sources, and overseeing any changes that could impact manufacturing processes with external CMOs.
Your major accountabilities:
- Define a quality control transfer strategy for the defined projects.
- Define a manufacturing and quality control transfer strategy for the defined projects.
- Define a lifecycle strategy for the assigned molecules and FDFs.
Your specific accountabilities:
- Assessment of analytical instruction for raw materials, excipients and finished products.
- Definition of analytical method transfer strategy for the defined TT projects.
- Review and approval of analytical protocols and reports.
- Evaluation of proposed manufacturing process steps
- Management and review of the documentation provided by Receiving unit CMO's in reference to the Manufacturing process (Master batch record & Process validation report). Collect the Master Batch records from Sending unit CMO's and to review and file into QMS system.
- Write, review and approve technical documents: master batch manufacturing records, analytical methods, material lists, specifications, environmental conditions, stability studies, SOPs, Quality Agreements, etc.
- Write, execute or review qualifications (equipment, utilities, facilities, suppliers, providers, etc.) and validations (e.g. process, cleaning, transport, etc.).
- Design transport routes, validation protocols, evaluate temperature excursions and define improvement actions for a stable supply chain.
- Participate in the assigned projects.
We would like you to have:
- University degree in Life Sciences or Engineering (Pharmacy, Chemistry, or Biology preferred). Master in Pharmaceutical Industry is a plus.
- Minimum of 2 years' experience in analytical quality control of cold chain products, in a Quality role within a pharmaceutical company.
- Proficiency in GMP, Quality Management Systems (deviations, complaints, audits).
- Expert in IT tools: MS Office, SAP, LIMS.
- Analytical thinking, problem solving, initiative, results orientation, attention to detail.
- Languages: English and Spanish.
- Availability to travel: 15%
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, one in the Middle East and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.
Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals 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 teams that will inspire you every day with a passionate, dynamic, 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:
If you want to join us, this is your opportunity
WE COUNT ON YOU, YOU COUNT ON US
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.
