Support External Quality Control SpecialistNeuraxpharm is looking for a Support External Quality Control Specialist based in Sant Joan Despí (temporary contract).
Your MissionProvide technical and operational support in External Quality Control activities related to the evaluation, follow‐up and documentation of analytical methods applied to raw materials, semi‐finished products and finished pharmaceutical products, under the supervision of the responsible manager.
The role contributes to ensuring that analytical methods validated or transferred by external manufacturers (CMOs/CROs) are executed and documented in compliance with internal procedures, GMP requirements and applicable guidelines, ensuring proper documentation control, traceability and material management throughout the product lifecycle.
Your Major Accountabilities
Support the review of analytical method validation protocols and reports for raw materials (excipients and APIs) and finished dosage forms generated by CMOs/CROs, following defined criteria and under supervision.
Typical analytical techniques include HPLC, GC, potentiometry, Karl Fischer, etc.
Assist in the management and follow‐up of analytical method transfer protocols and reports between sending and receiving laboratories, ensuring documentation completeness and correct filing.
Collect, organize and archive analytical methods and related documentation received from CMOs/CROs in the Quality Management System (QMS), ensuring correct traceability.
Manage the logistics and control of materials required for analytical activities (reference standards, samples, chromatographic columns, consumables), ensuring availability and correct identification.
Perform operational follow‐up of external analytical activities, collect results, review basic data and raise deviations or issues to the project or QC responsible.
Support in the administrative and basic technical review of documentation related to analytical validation and transfer activities, in line with requirements of different markets (EU, FDA, etc.).
We Would Like You To Have
Technical Education in Laboratory Operations or equivalent technical education in the chemical field.
English Intermediate level (spoken, read and written).
About UsNeuraxpharm 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 40 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 approximately 1,000 employees and develops and commercialises CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East, one in Australia, and globally via partners in more than 50 countries.
Benefits
Individual professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
Attractive remuneration according to experience and skills provided.
An inspiring leadership team that drives performance.
An inclusive culture promoting diversity across the teams.
Learn more about our culture: www.neuraxpharm.com
Equal OpportunitiesAt Neuraxpharm, we ensure an inclusive, diverse, safe and respectful work environment for everyone in our organization. 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.
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