Responsible Person & QA Manager (Barcelona)

Responsible Person & QA Manager (Barcelona)

07 ago
|
Vivanta
|
Barcelona

07 ago

Vivanta

Barcelona

ppbJob Title: /bResponsible Person QA Manager /ppbLocation: /bBarcelona, Spain (central location) /ppbDepartment: /bQuality Technical Services /ppbIndustry: /bPharmaceutical (Generics) /ppbCompany: /bMSN Laboratories Pvt. Ltd. (Vivanta Generics) /ph3About MSN Group /h3pMSN Group is the fastest growing research-based pharmaceutical company based out of India with various other entities across multiple countries. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India USA. /ppInnovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation. /ppThe group has an integrated RD centre for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: /pulliMore than 900+ national and international patents /lili300+ Formulations, covering over 35 major therapies /liliWon the trust of more than 40 Million patients across 80+ countries globally /li /ulpMSN is present on the European market in 15+ countries under the Vivanta Generics label and the MSN labs label. In Europe, the company has offices in Spain, the UK, Poland and Germany. /ph3Position Overview /h3pResponsible for ensuring compliance with EU GMDP requirements, establishing and maintaining the EU Quality Management System,



acting as the Responsible Person in the EU and supporting the Qualified Person activities, and improving quality across European operations. The position is based in Barcelona within the Technical Services department of Vivanta Generics/MSN Labs, reporting to the Director of Technical Services, with a dotted line to the Director Quality. The position follows a hybrid work schedule. While working from home is accepted and supported, a minimum office presence of three days per week is expected. /ph3Job Responsibilities /h3ulliReview and maintain the EU QMS. /liliPerform RP market release by reviewing CoAs, BRCs and supply chain documents. /liliReview supply chain processes. /liliCoordinate and perform audits of API, CMO, storage and testing sites. /liliManage Quality Technical Agreements, vendor qualification and customer verification. /liliManage change controls, deviations, CAPAs, OOS/OOT and risk assessments. /liliSupport analytical method transfers. /liliReview warehouse licences, transportation and logistics. /liliSupport business teams. /liliProvide QA support for the European Pharmacovigilance function. /liliPrepare SOPs, policies and quality documents. /liliCoordinate evaluate company GXP training. /liliConduct self-inspections. /liliManage complaints, recalls, returns and PQRs. /li /ulh3Academic Background and Experience /h3ulliPharmacy degree or equivalent. /liliMinimum 5 years in QA and at least 2 years as Responsible Person. /liliOverall experience: 8 years or more in a Quality function, preferably in the pharmaceutical sector. /li /ulh3Skills /h3ulliEU GMP/GDP knowledge /liliEstablish and maintain Quality Management Systems /li /ul /p #J-18808-Ljbffr

📌 Responsible Person & QA Manager (Barcelona)
🏢 Vivanta
📍 Barcelona

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