Qa Officer

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 &