Qa Officer

Sandoz Inc.; Portugal; On-site; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Salário competitivo

Ambiente de carreira flexível

Trabalho híbrido

Job summary

A equipa portuguesa da Sandoz está à procura de uma profissional de Quality Assurance para monitorizar GxP, investigar não conformidades e coordenar melhorias de qualidade no âmbito local.

A função envolve manter o sistema de qualidade (QMS) e SOPs, assegurar conformidade com regras cGMP/GDP e apoiar contactos com autoridades regulatórias, SCM e Medical. A posição requer experiência de 3+ anos, fluência em Português e Inglês e perfil colaborativo.

Qualifications

• 3 anos de experiência em QA em operações comerciais.
• Experiência com QMS (Quality Management System).
• Experiência intercultural e colaboração entre equipas.

Responsibilities

• Realizar monitorização GxP em todas as secções e investigar não conformidades.
• Implementar e manter o Quality System local e SOPs para atividades cGMP/GDP.
• Garantir conformidade com regulamentação local e internacional e apoiar com training.
• Lançar e acompanhar o Change Control e gestão de pedidos de alteração.
• Gestão de reclamações, recalls potenciais e falsificações conforme manuais da qualidade.

Skills

GxP monitorização

QA investigaçōes

Ligações regulatórias

Experiência intercultural

Fluência em Português

Tools

QMS

Job description

Job Description Summary

A nossa equipa portuguesa está a contratar!

Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Major accountabilities:

• Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, Follow up the corrective actions.
• Coordinate implementation of quality system and procedures for the implementation of Sandoz Quality Manual and quality agreements.
• Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Sandoz Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
• Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
• Establish a good working relationship with the Supply Chain Management (SCM), DRA and Medical departments.
• Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance as applicable.
• Ensure that all incoming drug products are inspected prior to release to the market in accordance with the current in place procedures, registered specifications and with local/international regulations: Ensure release for distribution according to Global and Local procedures - including product return management.
• Ensure that an effective Change Control process is in place.
• Manage complaints, elevate potential recalls, counterfeits and product tampering according to the Sandoz Corporate Quality Manual and local written procedures.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt
• Ensure that Change requests, are managed according to the Sandoz SOPs from receipt, through to the implementation and closure, when applicable.

Major accountabilities:

• Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, Follow up the corrective actions.
• Archive relative documentations.
• Coordinate implementation of quality system and procedures for the implementation of Sandoz Quality Manual and quality agreements.
• Ensure that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Sandoz Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
• Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country.
• Establish a good working relationship with the Supply Chain Management (SCM), DRA and Medical departments.
• Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance as applicable.
• Ensure that all incoming drug products are inspected prior to release to the market in accordance with the current in place procedures, registered specifications and with local/international regulations: Ensure release for distribution according to Global and Local procedures - including product return management.
• Ensure that an effective Change Control process is in place.
• Manage complaints, elevate potential recalls, counterfeits and product tampering according to the Sandoz Corporate Quality Manual and local written procedures.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt
• Ensure that Change requests, are managed according to the Sandoz SOPs from receipt, through to the implementation and closure, when applicable.

What you need to bring to the role:

• 3 years' experience on Quality Assurance topics in commercial operations.
• Experience with QMS
• Cross Cultural Experience.

What you need to bring to the role:

• 3 years' experience on Quality Assurance topics in commercial operations.
• Experience with QMS
• Cross Cultural Experience.
• Collaborating across boundaries.
• Fluent Portuguese & English.

What You'll Receive

Sandoz compensation is determined by job level, qualifications, niche skills, experience, and location within company salary ranges. Fully proficient and highly effective employees can expect a starting salary around market median, with those new to the level or with less functional depth at the lower end of the range and those with sustained superior or niche skills towards the higher end of the range. Internal equity and external market data inform our range placement. Annual salary reviews consider performance outcomes, market alignment, and business needs.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

Skills Desired

Continued Learning, Dealing With Ambiguity, Good Documentation Practice, Guideline, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Regulation, Self-Awareness, Technological Expertise

Sandoz is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our global...