Quality Control Specialist
hace 1 mes
Quality Control Specialist – External Manufacturing Management
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 QUALITY CONTROL SPECIALIST - EMM (temporary) based in Sant Joan Despí, Barcelona
Your mission:
Reporting to External Manufacturing Manager she/he will be responsible for the evaluation and assessment of analytical instruction for Raw Materials (excipients and pharmaceuticals active ingredients), Semi finished (for solids and liquid forms, including sterile products) and Pharmaceutical Finished products: for solids and liquid forms (including sterile FDF). She/he will be responsible for the definition of analytical method transfer strategy for the defined TT projects. At the same time, she/he will provide technical support and to coordinate Quality Control responsible of QC labs TT units, QA specialist and regulatory specialists towards the execution of all activities, follow up and achievement of objectives, supervise all the activities and results of the work defined in the analytical transfer program/project. Finally she/he will be responsible for writing or approving the technical documentation of the EMM department in accordance with current quality regulations.
Your major accountabilities:
Revision of Analytical method Validation Protocols & Reports of new analytical methods for active pharmaceutical ingredients and finished dosage forms from CMO’s/CRO’s. Whenever required, to provide support for the Protocol & Report edition or even to write them. Specific analytical techniques: HPLC, GC, potentiometry, KF, etc. Revision of Analytical method Transfer Protocols & Reports of corresponding analytical methods for active pharmaceutical ingredients and finished dosage forms between Sending unit CMO and Receiving unit CMO. Whenever required, to provide support for the Protocol & Report edition or even to write them. Specific analytical techniques: HPLC, GC, potentiometry, KF, etc. Writing of technical reports and SOP’s (Standards Operating Procedures). Continuous learning for being the most updated possible in analytical requirements described in guidelines, Pharmacopeias, country requirements, etc. Collect the Analytical method from CMO’s (Sending unit – Receiving unit) and to file into NxP QMS system. Management and review of the documentation provided by CRO’s and CMO’s in reference to the analytical validations & transfers activities according to different markets (FDA, US, ANVISA, EUR). Management of all the material (such standards, samples of finished product, HPLC columns, etc.) needed to complete activities. Follow-up of the experimental work of the CMO, as well as the review of the raw data generated by them. To become an Expert in terms of analysis for assigned FDF’s. Act as an interlocutor between the transferring laboratory and receiving laboratory. Follow-up of the analytical activities of the project. Support to Regulatory Affairs team to answer the deficiency letters from agencies or to clients' queries in life cycle management projects to get the dossier approval. Within the project life cycle, to evaluate and to improve the analytical method, based on experience and analytical issues (analytical troubleshooting).We would like you to have:
Bachelor’s degree in pharmacy or chemistry Experience minimum demonstrable of 1-2 years as technology transfer in Quality Control of a pharmaceutical company. Extensive knowledge of basic and specific manufacturing and analytical methods for pharmaceutical products: Analytical Method Transfer / Validation, ICH stability guidelines, GMP Guidelines, Change Control procedures and good understanding of the Variation Guideline. Intermediate level of English and Spanish. Specific Knowledge: Quality Systems: GMPs, GLPs, Pharmacopoeia, ICH regulations and Office tools (MS Office) and LIMS and SAP software. Key Capabilities: Analytical thinking, and Quality oriented, with organizational and prioritization skills. Availability to travel: 10 % Immediate availability. 5 months of temporary agreement.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 teamInterested 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
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