22 feb
Whatjobs
Estado de México
Position: Clinical Operation Quality Assurance Specialist Location: Madrid Experience: +2 years of experience in Pharma sector in quality assurance positions and at least 3 years in clinical operation positions or +5 years in clinical operation positions in Pharma sector.
Want to know more?
"Exeltis is the exaltation of excellence, innovation, and diversity." Our philosophy, our way of being and working, and what makes us different, is captured in our emblem "Rethinking Healthcare." What are we looking for?
The position is responsible for leading the creation, implementation, and monitoring of standard operating procedures (SOPs), manuals, plans, and procedures within the Clin Ops team.
This role is key to ensuring continuous compliance with regulatory, internal, and industry standards by establishing efficient internal controls.
The challenge!
Development and Management of SOPs and procedures.
Ensuring Compliance with Procedures by implementing periodic internal controls.
CAPA management: oversee the follow-up CAPAs resulting from internal and external audits and regulatory inspection.
Collaborate with the team to identify, implement and evaluate corrective and preventive solutions to address audit and inspection findings.
Training and development of personnel: develop and implement training programs for all staff to ensure they are up-to-date on current legislation, regulatory updates, and relevant pathologies.
Ensure all team members are trained to execute their roles effectively and in compliance with established standards.
Management of regulatory and legislative updates by monitoring and staying informed about legislative and regulatory changes impacting global clinical operations and updating SOPs as needed.
Active end-to-end support throughout the regulatory inspection and audit process.
Risk Assessment plan creation in collaboration with the clinical project managers assigned to the projects.
Perform internal SOP/process compliance checks for the ClinOps department.
Standardize Clin Ops Plans and Manuals and provide guidance and advice to the Clin Ops team on QA matters.
Ensure compliance with SOP Training Matrix and training timelines within corporate systems.
Development of a QMP (Quality Management Plan) Template and customize it as needed per study requirements.
Develop Clin Ops QA Metrics and KPIs.
Ensure adequacy of the Clin Ops team for document maintenance and renewal.
What do you need?
Degree in Health Sciences (e.g., Chemistry, Pharmacy, Biology, or Medicine) with supplementary knowledge of clinical operation procedures/activities, Quality, and GxP.
Master is a plus.
Languages: Fluent Spanish and English; knowledge of other languages will be an asset.
Experience: +2 years of experience in Pharma sector in quality assurance positions and at least 3 years in clinical operation positions or +5 years in clinical operation positions in Pharma sector.
Specific Knowledge: In-depth knowledge of international regulation and experience in creating SOPs and operational procedures.
Personal skills: proactivity, adaptability/flexibility, high level of strategy, organizational and communication skills are essential.
Ability to work in a global, multicultural environment.
Ability to train and educate multidisciplinary teams.
Travels: Willingness to travel 30%.
Our benefits!
Flexible start time from Monday to Friday (full-time 40 hours)
Permanent contract Attractive salary package Life and accident insurance Meal vouchers Co-payment in voluntary health insurance Benefits and Savings Club Company parking Development plans, internal mobility policy Many more!
What will the Selection process be like?
Stay tuned to your phone and email!
The first thing we will likely do is contact you through one of the two channels.
Prepare well!
We will continue with an in-person/virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test.
Wait for the result!
We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.
COMMITMENT TO EQUAL OPPORTUNITIES Exeltis is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
#J-18808-Ljbffr
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.