Overview
Responsible Person & QA Manager Jobs in Barcelona, Catalonia, Spain at Vivanta
Title: Responsible Person & QA Manager
Company: Vivanta
Location: Barcelona, Catalonia, Spain
Job Title: Responsible Person & QA Manager
Location: Barcelona, Spain (central location)
Department: Quality & Technical Services
Industry: Pharmaceutical (Generics)
Company: MSN Laboratories Pvt. Ltd. (Vivanta Generics)
About MSN Group
MSN 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.
Innovation 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.
The group has an integrated R&D 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:
- More than 900+ national and international patents
- Product portfolio featuring over 450 + APIs
- 300+ Formulations, covering over 35 major therapies
- Won the trust of more than 40 Million patients across 80+ countries globally
MSN 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.
Position Overview
Responsible 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.
Job Responsibilities
- Review and maintain the EU QMS.
- Perform RP market release by reviewing CoAs, BRCs and supply chain documents.
- Review supply chain processes.
- Coordinate and perform audits of API, CMO, storage and testing sites.
- Manage Quality Technical Agreements, vendor qualification and customer verification.
- Manage change controls, deviations, CAPAs, OOS/OOT and risk assessments.
- Support analytical method transfers.
- Review warehouse licences, transportation and logistics.
- Support business teams.
- Provide QA support for the European Pharmacovigilance function.
- Prepare SOPs, policies and quality documents.
- Coordinate & evaluate company GXP training.
- Conduct self-inspections.
- Manage complaints, recalls, returns and PQRs.
- Perform supplier/customer due diligence.
Academic Background and Experience
- Pharmacy degree or equivalent.
- Minimum 5 years in QA and at least 2 years as Responsible Person.
- Overall experience: 8 years or more in a Quality function, preferably in the pharmaceutical sector.
Skills
- EU GMP/GDP knowledge
- Establish and maintain Quality Management Systems
- Auditing of GMP/GDP-licensed sites
- Regulatory Compliance
- Documentation
- Fluency in English and Spanish
- Communication & Leadership
