QA Officer

sandoz; Porto Salvo; Hybrid; EUR 45,000 - 60,000; Full time

Job summary

Sandoz in Portugal is recruiting a Quality Assurance professional to support the commercial operations and regulatory compliance across the local market. The role focuses on governance of GxP, QA investigations, and ongoing quality systems alignment.

You'll coordinate with Supply Chain, Regulatory Authorities, Medical, and external partners to ensure compliant handling, release, and distribution of pharmaceutical products.

Qualifications

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

Responsibilities

• 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, upscale 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.

Skills

GxP monitoring

QA investigation

QMS

Cross cultural

Collaboration

Portuguese

English

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, upscale 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!

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