Pharma QA Specialist — Compliance & Quality Systems

sandoz; Porto Salvo; Hybrid; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

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

Aufgaben

• 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.

Kenntnisse

GxP monitoring

QA investigation

QMS

Cross cultural

Collaboration

Portuguese

English

Jobbeschreibung

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.