QA Officer

PT13 (FCRS = PT013) PT Sandoz; Porto Salvo; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

A Sandoz está à procura de um profissional de Quality Assurance para assegurar a conformidade, monitorizar GxP e otimizar o sistema de qualidade em operações comerciais em Portugal. O papel envolve coordenação com SCM, DRA e parceiros, bem como gestão de mudanças e investigações de não conformidades.

O candidato trabalhará em ambiente de qualidade internacional, com fluência em Português e Inglês, assegurando o alinhamento com as normas gmp/gdp e uma cultura de melhoria contínua.

Qualifications

• 3 anos de experiência em QA (Quality Assurance) em operações comerciais.
• Experiência com QMS e experiência transcultural.
• Colaboração entre áreas e fluência em Português e Inglês.

Responsibilities

• Monitorização GxP on todas as secções e investigar não-conformidades.
• Arquivar documentação relevante e apoiar ações corretivas.
• Implementação de sistema de qualidade e procedimentos conforme o Sandoz Quality Manual.
• Assegurar conformidade cGMP/GDP e treinar equipes internas.
• Estabelecer relacionamento com SCM, DRA e departamentos médicos.
• Coordenação com autoridades regulatórias e parceiros locais.
• Inspeção de produtos antes do lançamento e gestão de mudanças.

Skills

Continued Learning

Dealing With Ambiguity

Good Documentation Practice

Guideline

Knowledge Of Capa

Qa

Quality Management

Regulation

Self-Awareness

Technological Expertise

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.
• 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, escape 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.
• 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

Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!