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Gmp Audit Technical Manager (Quality Specialist)

Gmp Audit Technical Manager (Quality Specialist)
Empresa:

Rephine


Detalles de la oferta

About the jobWe are global experts in quality assurance & GxP compliance across Pharmaceutical, Biotech & Medical device manufacturing supply chains.Rephine Barcelona is part of the Rephine Group, with offices at Spain (Barcelona), the UK (Stevenage) and China (Shanghai).Are you a Pharmaceutical and Life Sciences lover? Are you oriented to work on a team? Are you passionate about learning? Do you want to make a difference by managing multi-Projects? Are you ready to work in Global multi-site company?We are looking for a Audit Technical Manager to join our team of experts in coordinating and overseeing Good Manufacturing Practice (GMP) audits.Your Challenge:As an Audit Technical Manager, you will play a critical role in ensuring auditors are aligned in technical knowledge and criteria, and in ensuring compliance with approved methodologies and processes. You will facilitate the preparation, execution, and reporting of audits.Your main responsibilities:Reporting to the Technical Manager, your key responsibilities will include:• Ensuring that audits are well-prepared, approached, executed, and reported.• Monitoring the schedule and timing of the audit life cycle.• Ensuring the absence of conflicts of interest and maintaining confidentiality in all audit activities.• Reviewing audit reports to ensure they meet the standards of Rephine Group and clients' requirements.• Requesting CAPAs (Corrective and Preventive Actions) from auditees, evaluating their consistency withobservations, and following up until their closure. You will transmit reviewed CAPAs to the relevant clients.• Providing technical customer service.• Following Quality System procedures and participating in the investigation of internal incidents.• Participating in and/or performing audits.Your team:If there is something that characterizes Rephine team, it is our absolute commitment to our customers and it is precisely that which keeps us in constant growth. The involvement, experience, and expertise of our consultants is our greatest asset.Join our young and enthusiastic team, share our values & goals, and grow with us. You can be part of the success of our projects.This Job is for you IF:•Bachelor's or master's degree in a relevant scientific field (e.g., chemistry, biology, pharmacy, engineering)•Minimum of 3 years of experience in a GMP organization (pharmaceutical, biotech, or medical device industry)•Strong knowledge of relevant regulations and guidelines (e.g., FDA, EMA, ICH)•Excellent leadership and communication skills•Ability to work independently and manage multiple projects simultaneously.•Willingness to travel up to 20% of the time.•Strong teamwork skills.•Fluent in both Spanish and English. Other languages are highly valuable.•Eager to learn and motivated.Your career at Rephine:We are growing and constantly evolving, looking for professionals who want to stay and develop their career with us.We offer:Benefits: Competitive salary according to experience, additional extra-legal vacation days, and other competitive benefits.Teamwork: highly qualified staff with numerous years of experience, always available to help.Flexibility: Hybrid mode, autonomy, reduced workday each Friday, flexible hours.Global Company: Growing global company and multicultural team.Learning program: Training and development programContinuous training and English and Chinese lessonsOccasionally teambuilding, social events and Rephiesta.Excellent culture and work environment. Young and enthusiastic team of consultants.Why Rephine?:During the 20+ years, we have been able to work closely with many of the largest companies in Life Sciences. We have joined their teams, worked with them at their facilities and advised them on how to improve their manufacturing quality processes. We are growing and in constant evolution, looking for professionals who want to stay and develop with us.Visit our career site for more information: Careers - RephineApplications need to be in English.#J-18808-Ljbffr


Fuente: Allthetopbananas_Ppc

Requisitos

Gmp Audit Technical Manager (Quality Specialist)
Empresa:

Rephine


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